Product Code: CGN FDA class 2 21 CFR 862.1295

Acid, Folic, Radioimmunoassay

Clinical Chemistry

The Radioimmunoassay, Folic Acid test system (product code CGN) is an in-vitro diagnostic device used in clinical chemistry to measure folic acid (folate) levels in serum or whole blood using a radioimmunoassay method, supporting the diagnosis of folate deficiency and related conditions. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1295 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code CGN in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: CGN
Device Class: FDA class 2
Regulation Number: 862.1295
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233060	Elecsys Folate III	Jun 17, 2024	Substantially Equivalent	Roche Diagnostics
K223590	Access Folate Assay	Aug 23, 2023	Substantially Equivalent	Beckman Coulter, Inc.
K192586	LIAISON® Folate	May 06, 2020	Substantially Equivalent	DiaSorin, Inc.
K172201	Atellica IM Folate Assay	Apr 12, 2018	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K161646	Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set	Nov 04, 2016	Substantially Equivalent	Diazyme Laboratories
K141426	ELECSYS FOLATE III	Oct 17, 2014	Substantially Equivalent	Roche Diagnostics
K103716	ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET	May 12, 2011	Substantially Equivalent	Roche Diagnostics
K092740	ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74	Mar 05, 2010	Substantially Equivalent	Abbott Laboratories
K091332	AIA-PACK RBC FOLATE	Oct 02, 2009	Substantially Equivalent	Tosoh Bioscience, Inc.
K082340	ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS	Jun 19, 2009	Substantially Equivalent	Roche Diagnostics Corp.
K060774	FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208	Apr 21, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K051292	ELECSYS RBC FOLATE HEMOLYZED REAGENT	Jun 17, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K043318	MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY	Dec 23, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K031756	ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY	Jun 25, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K023397	ABBOTT ARCHITECT FOLATE	Dec 16, 2002	Substantially Equivalent	Abbott Laboratories
K010050	ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY	Feb 05, 2001	Substantially Equivalent	Bayer Diagnostics Corp.
K001266	VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA	May 02, 2000	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K993254	IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06	Nov 12, 1999	Substantially Equivalent	Diagnostic Products Corp.
K992365	AIA-PACK FOLATE ASSAY	Aug 10, 1999	Substantially Equivalent	Tosoh Medics, Inc.
K991582	CHIRON DIAGNOSTICS ACS: 180 FOLATE	Jun 30, 1999	Substantially Equivalent	Chiron Diagnostics Corp.
K984301	ABBOTT ARCHITECT FOLATE	Feb 05, 1999	Substantially Equivalent	Abbott Laboratories
K984166	VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3	Feb 05, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K981931	CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY	Aug 25, 1998	Substantially Equivalent	Roche Diagnostics/Boehringer Mannheim GmbH
K972232	ABBOTT AXSYM FOLATE	Jun 24, 1997	Substantially Equivalent	Abbott Laboratories
K964349	AIA-PACK FOLATE ASSAY	Nov 27, 1996	Substantially Equivalent	Tosoh Medics, Inc.
K960800	CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)	Jul 26, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K955434	ACCESS FOLATE ASSAY (MODIFICATION)	Jan 29, 1996	Substantially Equivalent	Beckman Coulter, Inc.
K954332	RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM	Jan 24, 1996	Substantially Equivalent	Bayer Corp.
K951155	CEDIA FOLATE (NO BOIL) ASSAY	Jun 29, 1995	Substantially Equivalent	Microgenics Corp.
K950292	FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM	May 02, 1995	Substantially Equivalent	Miles, Inc.
K943691	IMX FOLATE	Mar 23, 1995	Substantially Equivalent	Abbott Mfg., Inc.
K944212	RADIAS RED CELL FOLATE IMMUNOASAY	Feb 03, 1995	Substantially Equivalent	Bio-Rad
K946184	CEDIA(R) FOLATE (NO BOIL) ASSAY	Jan 17, 1995	Substantially Equivalent	Microgenics Corp.
K943297	CIBA CORNING ACS FOLATE ASSAY	Dec 12, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K943705	FOLIC ACID	Oct 31, 1994	Substantially Equivalent	Diagnostic Products Corp.
K943149	ACCESS RED BLOOD CELL FOLATE ASSAY	Aug 26, 1994	Substantially Equivalent	Beckman Coulter, Inc.
K935286	QUANTAPHASE II B12/FOLATE	Feb 18, 1994	Substantially Equivalent	Bio-Rad
K934121	VISTA FOLATE ASSAY	Oct 22, 1993	Substantially Equivalent	Syva Co.
K932887	ACCESS FOLATE ASSAY	Oct 12, 1993	Substantially Equivalent	Beckman Coulter, Inc.
K933571	RADIAS FOLATE ENZYME IMMUNOASSAY	Oct 01, 1993	Substantially Equivalent	Bio-Rad
K923286	STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY	Sep 17, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922823	ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS	Aug 05, 1992	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K921614	MILENIA FOLIC ACID	Jun 25, 1992	Substantially Equivalent	Diagnostic Products Corp.
K921689	CEDIA RED BLOOD CELL FOLATE REAGENT PACK	Jun 16, 1992	Substantially Equivalent	Microgenics Corp.
K893684	CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY	Jul 27, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K841302	DIAGNON FOLATE 125I RIA KIT	Jun 22, 1984	Substantially Equivalent	Diagnon Corp.
K832712	FOLATE RADIOASSAY KIT CA-1562-125	Oct 04, 1983	Substantially Equivalent	Clinical Assays, Inc.
K822728	SOLID PHASE SIMUL TRAC VITAMIN B12	Nov 05, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K812979	VITAMIN B12/FOLATE DUAL RADIOASSAY KITS	Nov 24, 1981	Substantially Equivalent	Amersham Corp.
K811177	QUANTA PHASE VITAMIN B-12/FOLATE RAD	May 15, 1981	Substantially Equivalent	Bio-Rad
K810186	MICROMEDIC SYSTEMS' AUTOPAK	Feb 04, 1981	Substantially Equivalent	Micromedic Systems
K810001	'NO-BOIL' DUALCOUNT KIT	Jan 16, 1981	Substantially Equivalent	Diagnostic Products Corp.
K803060	FOLATE 125I RADIOIMMUNOASSAY	Dec 22, 1980	Substantially Equivalent	Corning Medical & Scientific
K801198	FOLATE RADIOASSAY KIT	Jul 21, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K800914	NO-BOIL FOLATE KIT #RP-500	May 08, 1980	Substantially Equivalent	Ria Products, Inc.
K792167	125 I FOLATE SOLID PHASE RADIOASSAY	Nov 13, 1979	Substantially Equivalent	Abbott Laboratories
K791079	GAMMADAB (125 1) FOLATE RADIOASSAY KIT	Jul 17, 1979	Substantially Equivalent	Clinical Assays, Inc.
K780557	FOLATE REAGENT KIT, ARIA-II SYSTEM	May 18, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780508	QUANTITOPE 125I-FOLATE RADIOASSAY KIT	May 03, 1978	Substantially Equivalent	Kallestad Laboratories, Inc.
K780148	RIA FOR FOLATES & VIT. B12, COMBO KIT	Mar 03, 1978	Substantially Equivalent	Ria Products, Inc.
K771597	IN VITRO FOLATE RADIOASSAY KIT	Sep 13, 1977	Substantially Equivalent	Clinical Assays, Inc.
K760262	RADIOASSY KIT, 3H-FOLATE	Aug 03, 1976	Substantially Equivalent	Diamond Shamrock Corp.
K760207	KIT, FOLATE RADIOASSAY SC.7	Jul 26, 1976	Substantially Equivalent	Amersham Corp.
K760133	PROCEDURE, RED CELL FOLATE ASSAY	Jul 20, 1976	Substantially Equivalent	Bio-Rad