Data / Medical devices / United States / Infrared Laboratory Systems dba SYNERMED

Infrared Laboratory Systems dba SYNERMED: FDA-registered device maker in Westfield, IN, United States, 36 510(k) clearances

Name: Infrared Laboratory Systems dba SYNERMED FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Infrared Laboratory Systems dba SYNERMED is registered with the FDA (registration 3003593973) in Westfield, IN, United States. It lists 41 device types. The FDA files 36 510(k) clearances under its listings, the newest dated June 24, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003593973
Address: 17408 Tiller Ct Ste 1900, Westfield, IN, United States, 46074
Owner or operator: Infrared Laboratory Systems, LLC (10038715)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: November 4, 2011
Registered through: 2026
Brand names listed: BTA C-101A CellSolutions General Cytology Preservative 12.5 x concentrate, BTA C-101B CellSolutions General Cytology Perservative 20 x concentrate, C-101-200 CellSolutions General Sytology Preservative 8 x 25vials x 10mL, C-101-25 CellSolutions General Cytology Preservative Clamshell Case 25 vials x 10mL, C-101-500 CellSolutions General Cytology Preservative 20 x 25 vials x 10mL, C-101G CellSolutions General Cytology Preservative 4x1 Liter, C-101L CellSolutions General Cytology Preservative 1 Liter, CB-102-25 CellSolutions Blue Preservative 25 cups x 40mL and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride	CHG	2	Manufacturer	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Manufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical Use	JJF	1	Manufacturer	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Manufacturer	accessdata.fda.gov
Bathophenanthroline, Colorimetry, Iron (Non-Heme)	CFM	1	Manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Repackager or relabeler	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Manufacturer	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Manufacturer	accessdata.fda.gov
Cresolphthalein Complexone, Calcium	CIC	2	Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Manufacturer	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Manufacturer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Contract manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Repackager or relabeler	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Repackager or relabeler	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	2	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Manufacturer	accessdata.fda.gov
Preservative, Cytological	LEA	1	Contract manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Repackager or relabeler	accessdata.fda.gov
System, Test, Sodium, Enzymatic Method	MZU	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, System, Potassium, Enzymatic Method	MZV	2	Repackager or relabeler	accessdata.fda.gov
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	JIQ	1	Manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 24, 2016	K153692	Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer	CGA	Substantially Equivalent	Infrared Laboratory Systems, LLC (Dba Synermed)	accessdata.fda.gov
February 21, 2014	K133710	LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS	DKB	Substantially Equivalent	Lin-Zhi International, Inc.	accessdata.fda.gov
August 14, 2009	K091455	DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL	MZV	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
November 12, 2008	K082763	DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B	MZU	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
January 22, 2008	K072523	DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS	LBR	Substantially Equivalent	General Atomics	accessdata.fda.gov
January 3, 2008	K072395	DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS	LBS	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
February 24, 1998	K974909	SYNERMED CREATININE REAGENT KIT	CGX	Substantially Equivalent	Synermed Intl., Inc.	accessdata.fda.gov
September 25, 1997	K973109	SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT	CIG	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
August 7, 1997	K972716	SYNERMED TOTAL BILIRUBIN REAGENT KIT	CIG	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
June 26, 1997	K971491	SYNERMED IR 200 CHEMISTRY ANALYZER	JJF	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
March 3, 1997	K962479	SYNERMED ISE REAGENTS	CGZ	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
August 31, 1995	K953395	SYNERMED CALCIUM REAGENT KIT	CJY	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
June 20, 1995	K952179	SYNERMED ISE REAGENTS	JGS	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
May 3, 1994	K941091	SYNERMED AMYLASE REAGENT KIT	JFJ	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
April 26, 1994	K935662	SYNERMED IR 500 CHEMISTRY ANALYZER	JIQ	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
April 21, 1994	K940571	SYNERMEDIR CAL I AND SYNERMED IR CAL II	JIX	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
September 8, 1993	K931986	AMP ALKALINE PHOSPHATASE REAGENT KIT	CJE	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
September 8, 1993	K931958	SYNERMED GGT REAGENT KIT	JQB	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
May 11, 1993	K930932	SYNERMED CREATINE KINASE REAGENT KIT	CGS	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
December 3, 1992	K924428	SYNERMED ENZYMATIC CO2 REAGENT KIT	KHS	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
September 22, 1992	K923414	SYNERMED 600 NM URIC ACID REAGENT KIT	KNK	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
July 21, 1992	K922784	SYNERMED UIBC REAGENT KIT	JMO	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
May 7, 1992	K921016	SYNERMED ALT/GPT REAGENT KIT	CKA	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
March 23, 1992	K921025	SYNERMED LDHH-L REAGENT KIT	CFJ	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
January 27, 1992	K915555	SYNERMED AST/GOT REAGENT KIT	CIT	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
July 30, 1991	K912912	SYNERMED SERUM IRON-600 REAGENT KIT	CFM	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
July 17, 1991	K912569	SYNERMED PHOSPHORUS REAGENT KIT	CEO	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
June 3, 1991	K911248	SYNERMED UREA NITROGEN REAGENT KIT	CDQ	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
October 12, 1990	K903543	SYNERMED ALBUMIN REAGENT KIT	CIX	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
October 4, 1990	K903233	SYNERMED CALCIUM REAGENT KIT	CIC	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
October 1, 1990	K903015	SYNERMED CHOLESTEROL REAGENT KIT	CHH	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
September 13, 1990	K903063	SYNERMED GLUCOSE REAGENT KIT	CGA	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
September 7, 1990	K903511	SYNERMED TOTAL PROTEIN REAGENT KIT	CEK	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
August 9, 1990	K903103	SYNERMED CHLORIDE REAGENT KIT	CHG	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
July 31, 1990	K902919	SYNERMED MAGNESIUM REAGENT KIT	JGJ	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov
July 27, 1990	K903016	SYNERMED TRIGLYCERIDES REAGENT KIT	CDT	Substantially Equivalent	Synermed, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 24, 2016. 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.