Acid, Folic, Radioimmunoassay

FDA product code CGN · 63 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1295
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2024-06-17

CGN 2024-06-17

Elecsys Folate III

Applicant Roche Diagnostics

K number K233060

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CGN 2023-08-23

Access Folate Assay

Applicant Beckman Coulter, Inc.

K number K223590

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CGN 2020-05-06

LIAISON® Folate

Applicant DiaSorin, Inc.

K number K192586

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CGN 2018-04-12

Atellica IM Folate Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K number K172201

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CGN 2016-11-04

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

Applicant Diazyme Laboratories

K number K161646

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CGN 2011-05-12

ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET

Applicant Roche Diagnostics

K number K103716

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CGN 2010-03-05

ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74

Applicant Abbott Laboratories

K number K092740

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CGN 2009-10-02

AIA-PACK RBC FOLATE

Applicant Tosoh Bioscience, Inc.

K number K091332

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CGN 2009-06-19

ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS

Applicant Roche Diagnostics Corp.

K number K082340

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CGN 2006-04-21

FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208

Applicant Beckman Coulter, Inc.

K number K060774

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CGN 2005-06-17

ELECSYS RBC FOLATE HEMOLYZED REAGENT

Applicant Roche Diagnostics Corp.

K number K051292

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CGN 2004-12-23

MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY

Applicant Roche Diagnostics Corp.

K number K043318

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CGN 2003-06-25

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY

Applicant Roche Diagnostics Corp.

K number K031756

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CGN 2002-12-16

ABBOTT ARCHITECT FOLATE

Applicant Abbott Laboratories

K number K023397

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CGN 2001-02-05

ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY

Applicant Bayer Diagnostics Corp.

K number K010050

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CGN 2000-05-02

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

Applicant Ortho-Clinical Diagnostics, Inc.

K number K001266

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CGN 1999-11-12

IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06

Applicant Diagnostic Products Corp.

K number K993254

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CGN 1999-08-10

AIA-PACK FOLATE ASSAY

Applicant Tosoh Medics, Inc.

K number K992365

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CGN 1999-06-30

CHIRON DIAGNOSTICS ACS: 180 FOLATE

Applicant Chiron Diagnostics Corp.

K number K991582

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CGN 1999-02-05

ABBOTT ARCHITECT FOLATE

Applicant Abbott Laboratories

K number K984301

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CGN 1999-02-05

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3

Applicant Ortho-Clinical Diagnostics, Inc.

K number K984166

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CGN 1998-08-25

CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY

Applicant Roche Diagnostics/Boehringer Mannheim GmbH

K number K981931

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CGN 1997-06-24

ABBOTT AXSYM FOLATE

Applicant Abbott Laboratories

K number K972232

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CGN 1996-11-27

AIA-PACK FOLATE ASSAY

Applicant Tosoh Medics, Inc.

K number K964349

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CGN 1996-07-26

CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)

Applicant Boehringer Mannheim Corp.

K number K960800

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CGN 1996-01-29

ACCESS FOLATE ASSAY (MODIFICATION)

Applicant Beckman Coulter, Inc.

K number K955434

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CGN 1996-01-24

RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

Applicant Bayer Corp.

K number K954332

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CGN 1995-06-29

CEDIA FOLATE (NO BOIL) ASSAY

Applicant Microgenics Corp.

K number K951155

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CGN 1995-05-02

FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM

Applicant Miles, Inc.

K number K950292

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CGN 1995-03-23

IMX FOLATE

Applicant Abbott Mfg., Inc.

K number K943691

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CGN 1995-02-03

RADIAS RED CELL FOLATE IMMUNOASAY

Applicant Bio-Rad

K number K944212

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CGN 1995-01-17

CEDIA(R) FOLATE (NO BOIL) ASSAY

Applicant Microgenics Corp.

K number K946184

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CGN 1994-12-12

CIBA CORNING ACS FOLATE ASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K943297

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CGN 1994-10-31

FOLIC ACID

Applicant Diagnostic Products Corp.

K number K943705

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CGN 1994-08-26

ACCESS RED BLOOD CELL FOLATE ASSAY

Applicant Beckman Coulter, Inc.

K number K943149

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CGN 1994-02-18

QUANTAPHASE II B12/FOLATE

Applicant Bio-Rad

K number K935286

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CGN 1993-10-22

VISTA FOLATE ASSAY

Applicant Syva Co.

K number K934121

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CGN 1993-10-12

ACCESS FOLATE ASSAY

Applicant Beckman Coulter, Inc.

K number K932887

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CGN 1993-10-01

RADIAS FOLATE ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K933571

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CGN 1992-09-17

STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY

Applicant Baxter Diagnostics, Inc.

K number K923286

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CGN 1992-08-05

ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS

Applicant Bio-Rad Laboratories, Inc.

K number K922823

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CGN 1992-06-25

MILENIA FOLIC ACID

Applicant Diagnostic Products Corp.

K number K921614

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CGN 1992-06-16

CEDIA RED BLOOD CELL FOLATE REAGENT PACK

Applicant Microgenics Corp.

K number K921689

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CGN 1989-07-27

CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K893684

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CGN 1984-06-22

DIAGNON FOLATE 125I RIA KIT

Applicant Diagnon Corp.

K number K841302

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CGN 1983-10-04

FOLATE RADIOASSAY KIT CA-1562-125

Applicant Clinical Assays, Inc.

K number K832712

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CGN 1982-11-05

SOLID PHASE SIMUL TRAC VITAMIN B12

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K822728

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CGN 1981-11-24

VITAMIN B12/FOLATE DUAL RADIOASSAY KITS

Applicant Amersham Corp.

K number K812979

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CGN 1981-05-15

QUANTA PHASE VITAMIN B-12/FOLATE RAD

Applicant Bio-Rad

K number K811177

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CGN 1981-02-04

MICROMEDIC SYSTEMS' AUTOPAK

Applicant Micromedic Systems

K number K810186

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CGN 1981-01-16

'NO-BOIL' DUALCOUNT KIT

Applicant Diagnostic Products Corp.

K number K810001

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CGN 1980-12-22

FOLATE 125I RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K803060

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CGN 1980-07-21

FOLATE RADIOASSAY KIT

Applicant Calbiochem-Behring Corp.

K number K801198

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CGN 1980-05-08

NO-BOIL FOLATE KIT #RP-500

Applicant Ria Products, Inc.

K number K800914

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CGN 1979-11-13

125 I FOLATE SOLID PHASE RADIOASSAY

Applicant Abbott Laboratories

K number K792167

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CGN 1979-07-17

GAMMADAB (125 1) FOLATE RADIOASSAY KIT

Applicant Clinical Assays, Inc.

K number K791079

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CGN 1978-05-18

FOLATE REAGENT KIT, ARIA-II SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K780557

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CGN 1978-05-03

QUANTITOPE 125I-FOLATE RADIOASSAY KIT

Applicant Kallestad Laboratories, Inc.

K number K780508

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CGN 1978-03-03

RIA FOR FOLATES & VIT. B12, COMBO KIT

Applicant Ria Products, Inc.

K number K780148

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CGN 1977-09-13

IN VITRO FOLATE RADIOASSAY KIT

Applicant Clinical Assays, Inc.

K number K771597

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CGN 1976-08-03

RADIOASSY KIT, 3H-FOLATE

Applicant Diamond Shamrock Corp.

K number K760262

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CGN 1976-07-26

KIT, FOLATE RADIOASSAY SC.7

Applicant Amersham Corp.

K number K760207

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CGN 1976-07-20

PROCEDURE, RED CELL FOLATE ASSAY

Applicant Bio-Rad

K number K760133

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