Data / Medical devices / United Kingdom / Siemens Healthcare Diagnostics Products Limited

Siemens Healthcare Diagnostics Products Limited: FDA-registered device maker in LLANBERIS Wales, United Kingdom, 117 510(k) clearances and 8 PMA approvals

Name: Siemens Healthcare Diagnostics Products Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Siemens Healthcare Diagnostics Products Limited is registered with the FDA (registration 3002806944) in LLANBERIS Wales, United Kingdom. It lists 85 device types. The FDA files 117 510(k) clearances and 8 PMA approvals under its listings, the newest dated December 4, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3002806944
Address: Glyn Rhonwy, LLANBERIS Wales, United Kingdom, LL55 4EL
Owner or operator: SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: February 12, 1998
Registered through: 2027
Brand names listed: 3gAllergy Specific Allergens: Basil (F269), Cacao (F93),, 600 Series Blood Gas, A482 (Native Ole e 1), A753 (Native Art v 1), A89 (Native Bet v 1), ACTH Control Module (ACT QC), ADVIA Centaur Anti-Thyroglobulin II (aTgII), ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) and more

Devices it lists

Device	Product code	Class	Role	Source
Acid Phosphatase (Prostatic), Tartrate Inhibited	JFH	2	Manufacturer	accessdata.fda.gov
Acid, Folic, Radioimmunoassay	CGN	2	Manufacturer	accessdata.fda.gov
Albumin, Rhodamine, Antigen, Antiserum, Control	DFJ	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer, Specification developer	accessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	NHX	2	Manufacturer	accessdata.fda.gov
Antibody Igm,If, Cytomegalovirus Virus	LKQ	2	Manufacturer	accessdata.fda.gov
Assay, Erythropoietin	GGT	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer, Specification developer	accessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	2	Manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Column Chromatography & Color Development, Hydroxyproline	JMM	1	Manufacturer	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Carbamazepine	KLT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digitoxin	LFM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digoxin	KXT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Theophylline	KLS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Valproic Acid	LEG	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Manufacturer	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Manufacturer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Manufacturer	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Manufacturer	accessdata.fda.gov
Ige, Peroxidase, Antigen, Antiserum, Control	DGO	2	Manufacturer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Manufacturer	accessdata.fda.gov
Immunochemical, Thyroglobulin Autoantibody	JNL	2	Specification developer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Manufacturer	accessdata.fda.gov
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	LOK	3	Manufacturer	accessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Manufacturer	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Radioassay, Intrinsic Factor Blocking Antibody	LIG	2	Manufacturer	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), Ferritin	JMG	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Acth	CKG	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Androstenedione	CIZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Calcitonin	JKR	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Cortisol	CGR	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Cyclic Gmp	CGT	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estriol	CGI	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Gastrin	CGC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Human Placental Lactogen	JMF	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoglobulins (D, E)	JHR	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroxine-Binding Globulin	CEE	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Tobramycin	KLB	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer, Specification developer	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Manufacturer	accessdata.fda.gov
System, Test, C-Reactive Protein	DCN	2	Manufacturer	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Manufacturer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Manufacturer	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Manufacturer	accessdata.fda.gov
System, Test, Radioallergosorbent (Rast) Immunological	DHB	2	Manufacturer	accessdata.fda.gov
System, Test, Thyroglobulin	MSW	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Manufacturer, Specification developer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Manufacturer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Manufacturer	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	MTG	3	Manufacturer	accessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	MTF	3	Manufacturer	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 117.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 4, 2025	K250816	ADVIA Centaur Anti-Thyroglobulin II (aTgII)	JNL	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 17, 2025	K250250	ADVIA Centaur Anti-Thyroid Peroxidase II	JZO	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
June 20, 2025	K242981	Atellica IM Thyroglobulin (Tg)	MSW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
March 13, 2024	K233946	IMMULITE® 2000 BR-MA	MOI	Substantially Equivalent	Siemens Healthcare Diagnostics Products, Ltd.	accessdata.fda.gov
September 8, 2023	K213510	IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA	LTK	Substantially Equivalent	Siemens Healthcare Diagnostics Products, Ltd.	accessdata.fda.gov
January 15, 2021	K202826	IMMULITE® 2000 Cortisol	CGR	Substantially Equivalent	Siemens Healthcare Diagnostics Products, Ltd.	accessdata.fda.gov
May 31, 2016	K160647	IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
March 3, 2016	K152061	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material	JZO	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
April 13, 2015	K150132	IMMULITE IGF Control Module, IMMULITE Gastrin Control Module	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
February 26, 2015	K143373	IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
February 25, 2015	K143636	IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
January 23, 2015	K143639	IMMULITE 2000 CEA Calibration Verification Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
January 14, 2015	K143504	IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
December 24, 2014	K143352	IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 30, 2014	K142878	IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 29, 2014	K142811	IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
August 19, 2014	K141772	IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 9, 2014	K141444	IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
June 24, 2014	K133816	IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
May 28, 2014	K132801	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
May 1, 2014	K140818	IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
April 1, 2014	K140541	IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
March 5, 2014	K140258	IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
January 14, 2014	K132739	IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 30, 2013	K133122	IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 25, 2013	K133124	IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 22, 2013	K133128	IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 10, 2013	K131662	IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
September 20, 2013	K132391	IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL	JJX	Substantially Equivalent	Siemens Helathcare Diagnostics, Inc.	accessdata.fda.gov
August 12, 2013	K131536	IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
April 4, 2013	K121576	IMMULITE 2000 ANTI-CCP IGG ASSAY	NHX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
January 6, 2012	K112523	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
September 21, 2011	K110061	CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
August 1, 2011	K101572	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
May 11, 2011	K100910	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6	DHB	Substantially Equivalent	Siemens Medical Solutions Diagnostics	accessdata.fda.gov
April 28, 2011	K103683	IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
March 28, 2011	K093987	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
September 30, 2010	K093107	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
May 13, 2010	K100433	IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,	LKQ	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
December 16, 2009	K091361	IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM	LIP	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
October 28, 2009	K091984	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6	DHB	Substantially Equivalent	Siemens Medical Solutions Diagnostics	accessdata.fda.gov
August 6, 2009	K091289	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
May 26, 2009	K090257	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
March 24, 2009	K083853	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
March 11, 2009	K083314	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	DHB	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
December 22, 2006	K063057	IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP	NQD	Substantially Equivalent	Diagnostic Products Corporation	accessdata.fda.gov
December 5, 2006	K063045	IMMULITE 2000, IMMULITE 2500 VANCOMYCIN	LEH	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
October 10, 2003	K032881	IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE	CDZ	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
December 9, 2002	K023304	IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL	JKR	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
August 21, 2002	K022603	IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER	CEW	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
July 22, 2002	K022118	IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)	JHX	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
May 30, 2002	K021208	IMMULITE 2000 MIXED ALLERGEN PANELS	DHB	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
May 30, 2002	K021206	IMMULITE 2000 SPECIFIC ALLERGENS	DHB	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
January 10, 2002	K012077	IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6	LFX	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
January 10, 2002	K012075	IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6	LGD	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
November 20, 2001	K013566	IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6	CEW	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
October 19, 2001	K013135	IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)	DHB	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
October 15, 2001	K013134	IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)	DHB	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
September 19, 2001	K012301	IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)	KXT	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
August 20, 2001	K012312	IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)	KLB	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
August 20, 2001	K012311	IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)	LCD	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 18, 2001	K010878	MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6	LGC	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
February 5, 2001	K003597	IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2	LPS	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
June 1, 2000	K000463	IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG	LYR	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
March 3, 2000	K000005	IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6	LEG	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
February 28, 2000	K000007	IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6	KLT	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
February 28, 2000	K000006	IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6	DIP	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
February 23, 2000	K000257	IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6	JFH	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
December 16, 1999	K993952	IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6	LFZ	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
November 17, 1999	K993251	IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6	LIG	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
November 12, 1999	K993254	IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06	CGN	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
July 12, 1999	K983203	IMMULITE EPO, MODEL #'S LKEPZ & LKEP1	GGT	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
May 13, 1999	K991096	IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06	JZO	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
May 13, 1999	K991094	IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6	JZO	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 27, 1999	K991277	MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5	DDR	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
March 12, 1999	K982468	IMMULITE 2000 THYROGLOBULIN MODEL L2KTY	MSW	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
March 12, 1999	K982466	IMMULITE THYROGLOBULIN MODEL LKTY	MSW	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
February 26, 1999	K990222	IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6	DHA	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
December 11, 1998	K982078	IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)	LFX	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
December 7, 1998	K983972	IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15	MMI	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
October 15, 1998	K983391	IMMULITE 2000 OM-MA MODEL L2KOP2	LTK	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
May 1, 1998	K980833	IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5	JMM	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 21, 1998	K980855	IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT	DHX	Substantially Equivalent	Dpc Cirrus	accessdata.fda.gov
January 2, 1998	K974634	IMMULITE FREE T3	CDP	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 24, 1997	K962936	IMMULITE TOXOPLASMA QUANTITATIVE IGG	LGD	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 10, 1997	K971051	IMMULITE THYROID AUTOANTIBODY CONTROL MODULE	JJX	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 8, 1997	K970227	IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER	JJE	Substantially Equivalent	Dpc Cirrus	accessdata.fda.gov
April 2, 1997	K963613	IMMULITE RUBELLA IGG	LFX	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
August 29, 1996	K963240	IMMULITE ACTH CONTROL MODULE (LACCM)	JJX	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
June 17, 1996	K950672	IMMULITE CMV IGG	LFZ	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
February 16, 1996	K960066	IMMULITE ACTH	CKG	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
December 21, 1995	K955440	IMMULITE SHBG (MODIFICATION)	CDZ	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
November 13, 1995	K954569	IMMULITE THEOPHYLLINE	KLS	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 3, 1995	K950072	IMMULITE(R) TBG	JJX	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
March 23, 1995	K943767	IMMULITE C-PEPTIDE	JKD	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
December 19, 1994	K944211	IMMULITE PROGESTERONE	JLS	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
December 19, 1994	K933212	IMMULITE RAPID TSH	JLW	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
October 27, 1994	K943235	IMMULITE DIGITOXIN	LFM	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
April 26, 1994	K935806	IMMULITE DHEA-S04	JKC	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
January 27, 1994	K931701	IMMULITE PAP	JFH	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 27, 2022	P210019	ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)	SEI	4	October 17, 2025	accessdata.fda.gov
May 11, 2007	P060005	IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS	MTG	21	September 22, 2026	accessdata.fda.gov
July 26, 2002	P010053	IMMULITE 2000 XPI ANTI-HBC IMG	SEI	14	August 30, 2023	accessdata.fda.gov
July 26, 2002	P010050	IMMULITE 2000 XPI HBSAG	LOM	20	September 18, 2025	accessdata.fda.gov
July 24, 2002	P010051	IMMULITE 2000 XPI ANTI-HBC	SEI	16	August 4, 2025	accessdata.fda.gov
July 22, 2002	P010052	IMMULITE 2000 XPI ANTI-HBS	SEI	15	September 18, 2025	accessdata.fda.gov
November 9, 2001	P010007	IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP	LOK	22	September 22, 2026	accessdata.fda.gov
September 15, 1995	P930027	IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS	MTF	34	September 22, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 13, 2026	99447	Class II	Ongoing	Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly	Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.	accessdata.fda.gov

Compare with other makers

Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.