Data / Medical devices / Japan / Tosoh Corp.

Tosoh Corp.: FDA-registered device maker in Chuo-ku Tokyo, Japan, 52 510(k) clearances and 1 PMA approval

Name: Tosoh Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tosoh Corp. is registered with the FDA (registration 8031673) in Chuo-ku Tokyo, Japan. It lists 63 device types. The FDA files 52 510(k) clearances and 1 PMA approval under its listings, the newest dated October 3, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8031673
FEI number: 2967
Address: 2-2-1 Yaesu, Chuo-ku Tokyo, Japan, 104-0028
Owner or operator: TOSOH BIOSCIENCE (8031673)
Roles: Exporter to the US
First device listed: April 4, 1994
Registered through: 2026
Brand names listed: AIA-PACK FOLATE Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, AIA-PACK 27.29 Calibrator Set, AIA-PACK 27.29 Sample Diluting Solution, AIA-PACK ?HCG Calibration Verification Test Set, AIA-PACK ?HCG Calibrator Set, AIA-PACK ?HCG Sample Diluting Solution, AIA-PACK ACTH Control Set and more

Devices it lists

Device	Product code	Class	Role	Source
Acid Phosphatase (Prostatic), Tartrate Inhibited	JFH	2	Exporter to the US	accessdata.fda.gov
Acid, Folic, Radioimmunoassay	CGN	2	Exporter to the US	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Exporter to the US	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Exporter to the US	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Exporter to the US	accessdata.fda.gov
Calibrator, Primary	JIS	2	Exporter to the US	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Exporter to the US	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Exporter to the US	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Exporter to the US	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Exporter to the US	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Exporter to the US	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Exporter to the US	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Exporter to the US	accessdata.fda.gov
Fibrin Split Products	GHH	2	Exporter to the US	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Exporter to the US	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Exporter to the US	accessdata.fda.gov
Fluorometric, Cortisol	JFT	2	Exporter to the US	accessdata.fda.gov
General Purpose Reagent	PPM	1	Exporter to the US	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Exporter to the US	accessdata.fda.gov
Hemoglobin A2 Quantitation	JPD	2	Exporter to the US	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Exporter to the US	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Exporter to the US	accessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	2	Exporter to the US	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Exporter to the US	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Exporter to the US	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Exporter to the US	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, 17-Hydroxyprogesterone	JLX	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Acth	CKG	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Exporter to the US	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Exporter to the US	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Exporter to the US	accessdata.fda.gov
System, Identification, Hepatitis B Antigen	KSJ	3	Exporter to the US	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Exporter to the US	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Exporter to the US	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Exporter to the US	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Exporter to the US	accessdata.fda.gov
System, Test, Osteocalcin	NEO	2	Exporter to the US	accessdata.fda.gov
System, Test, Thyroglobulin	MSW	2	Exporter to the US	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Exporter to the US	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Exporter to the US	accessdata.fda.gov
Test, Cystatin C	NDY	2	Exporter to the US	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Exporter to the US	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Exporter to the US	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Exporter to the US	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Exporter to the US	accessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	MTG	3	Exporter to the US	accessdata.fda.gov
Thyroglobulin, Antigen, Antiserum, Control	DDC	2	Exporter to the US	accessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	MTF	3	Exporter to the US	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Exporter to the US	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Exporter to the US	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 3, 2025	K250073	Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01	PDJ	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
August 24, 2020	K192380	ST AIA-PACK BNP	NBC	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
February 17, 2016	K160113	ST AIA-PACK hsE2 Calibrator Set	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 18, 2015	K153417	ST AIA-PACK PROG III Calibrator Set	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
October 26, 2015	K150270	ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set	MRG	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
July 2, 2015	K143075	ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set	CDZ	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 16, 2014	K143296	AIA-PACK C-Peptide Control Set	JJX	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 3, 2014	K143144	ST AIA-PACK PROG II Calibrator Set	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
April 10, 2014	K140648	ST AIA-PACK C-PEPTIDE II CALIBRATOR SET	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
February 8, 2013	K123131	ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI	MRG	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
June 15, 2012	K121533	ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET	LPS	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 1, 2011	K111335	ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321	CKG	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
August 5, 2011	K111762	ST AIA-PACK DHEA-S CALIBRATOR SET	JIT	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
September 14, 2010	K093960	ST AIA-PACK CYSTATIN C, MODEL 025217	NDY	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
October 2, 2009	K091332	AIA-PACK RBC FOLATE	CGN	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
September 16, 2008	K071132	G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8	LCP	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
June 21, 2007	K063605	ST AIA-PACK INTACT PTH ASSAY	CEW	Substantially Equivalent	Tosoh Bioscience, Inc.	accessdata.fda.gov
December 23, 2002	K023240	ST AIA-PACK CA 19-9	NIG	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
December 18, 2002	K023893	ST AIA-PACK CEA ENZYME IMMUNOASSAY	DHX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 17, 2002	K023894	ST AIA-PACK AFP ENZYME IMMUNOASSAY	LOJ	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 17, 2002	K023091	ST AIA-PACK TESTOSTERONE ASSAY	CDZ	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 6, 2002	K023891	ST AIA-PACK CA 125 ENZYME IMMUNOASSAY	LTK	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 14, 2001	K012820	AIA-PACK CTNI 2ND-GEN ASSAY	MMI	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
August 16, 2001	K010796	AIA-PACK BRCA, ST AIA PACK BRCA	MOI	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
August 10, 1999	K992365	AIA-PACK FOLATE ASSAY	CGN	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
May 11, 1999	K991252	AIA-PACK FT3 ASSAY	CDP	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
October 8, 1998	K981522	AIA-PACK TGAB ASSAY	JZO	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
October 8, 1998	K981521	AIA-PACK TPOAB ASSAY	JZO	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
May 28, 1998	K981012	AIA-PACK MYOGLOBIN ASSAY	DDR	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
October 3, 1997	K972697	AIA-PACK IGE II ASSAY	DGC	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
August 29, 1997	K972586	AIA-PACK TSH 3RD-GEN ASSAY	JLW	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
June 27, 1997	K971103	AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM	KHO	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
January 13, 1997	K964348	AIA-PACK B12 ASSAY	CDD	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 15, 1995	K954591	AIA-PACK CORT ASSAY	JFT	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
July 14, 1994	K936229	AIA-PACK TT3 ASSAY	CDP	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
September 21, 1993	K932178	AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
March 18, 1993	K924857	AIA-PACK CEA CALIBRATION VERIFICATION TEST SET	DHX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
March 4, 1993	K924860	AIA-PACK AFP CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
January 11, 1993	K924856	AIA-PACK PRL CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 28, 1992	K924853	AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
December 15, 1992	K924858	AIA-PACK FER CALIBRATION VERIFICATION TEST SET	DBF	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
November 16, 1992	K924863	AIA-PACK FSH CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
November 16, 1992	K924854	AIA-PACK PAP CALIBRATION VERIFICATION TEST SET	JJX	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
September 30, 1991	K913663	AIA-PACK T-U	KHQ	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
September 27, 1991	K913298	AIA-PACK CK-MB	JHX	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
September 10, 1991	K913493	AIA-PACK FT4	CEC	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
March 9, 1990	K896982	AIA-PACK T4	KLI	Substantially Equivalent	Tosoh Corp.	accessdata.fda.gov
February 26, 1990	K900440	AIA-PACK BMG	JZG	Substantially Equivalent	Tosoh Medics, Inc.	accessdata.fda.gov
April 8, 1987	K870521	TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY	JHI	Substantially Equivalent	Hybritech, Inc.	accessdata.fda.gov
January 5, 1987	K864945	TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY	JFH	Substantially Equivalent	Hybritech, Inc.	accessdata.fda.gov
November 21, 1986	K863861	TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA	JHI	Substantially Equivalent	Hybritech, Inc.	accessdata.fda.gov
October 8, 1986	K863345	TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY	DBF	Substantially Equivalent	Hybritech, Inc.	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 7, 1993	P910065	AIA-PACK PSA	MTF	9	June 18, 2019	accessdata.fda.gov

Compare with other makers

Updated October 3, 2025. 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.