Atlas FDA

CGN

64 FDA 510(k) clearances · Product code

65 daysmedian time to decision
178 days90th percentile
64clearances measured

FDA profile

Official device name
Acid, Folic, Radioimmunoassay
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1295
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 26 · 2009: 3 · 2011: 28 · 2012: 11 · 2022: 13 · 2024: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Elecsys Folate III (K233060)Roche Diagnostics2024-06-17
Access Folate Assay (K223590)Beckman Coulter, Inc.2023-08-23
LIAISON® Folate (K192586)DiaSorin, Inc.2020-05-06
Atellica IM Folate Assay (K172201)Siemens Healthcare Diagnostics, Inc.2018-04-12
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (K161646)Diazyme Laboratories2016-11-04
ELECSYS FOLATE III (K141426)Roche Diagnostics2014-10-17
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (K103716)Roche Diagnostics2011-05-12
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 (K092740)Abbott Laboratories2010-03-05
AIA-PACK RBC FOLATE (K091332)Tosoh Bioscience, Inc.2009-10-02
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS (K082340)Roche Diagnostics Corp.2009-06-19
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774)Beckman Coulter, Inc.2006-04-21
ELECSYS RBC FOLATE HEMOLYZED REAGENT (K051292)Roche Diagnostics Corp.2005-06-17
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318)Roche Diagnostics Corp.2004-12-23
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY (K031756)Roche Diagnostics Corp.2003-06-25
ABBOTT ARCHITECT FOLATE (K023397)Abbott Laboratories2002-12-16
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY (K010050)Bayer Diagnostics Corp.2001-02-05
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA (K001266)Ortho-Clinical Diagnostics, Inc.2000-05-02
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 (K993254)Diagnostic Products Corp.1999-11-12
AIA-PACK FOLATE ASSAY (K992365)Tosoh Medics, Inc.1999-08-10
CHIRON DIAGNOSTICS ACS: 180 FOLATE (K991582)Chiron Diagnostics Corp.1999-06-30
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 (K984166)Ortho-Clinical Diagnostics, Inc.1999-02-05
ABBOTT ARCHITECT FOLATE (K984301)Abbott Laboratories1999-02-05
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY (K981931)Roche Diagnostics/Boehringer Mannheim GmbH1998-08-25
ABBOTT AXSYM FOLATE (K972232)Abbott Laboratories1997-06-24
AIA-PACK FOLATE ASSAY (K964349)Tosoh Medics, Inc.1996-11-27
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) (K960800)Boehringer Mannheim Corp.1996-07-26
ACCESS FOLATE ASSAY (MODIFICATION) (K955434)Beckman Coulter, Inc.1996-01-29
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K954332)Bayer Corp.1996-01-24
CEDIA FOLATE (NO BOIL) ASSAY (K951155)Microgenics Corp.1995-06-29
FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K950292)Miles, Inc.1995-05-02
IMX FOLATE (K943691)Abbott Mfg., Inc.1995-03-23
RADIAS RED CELL FOLATE IMMUNOASAY (K944212)Bio-Rad1995-02-03
CEDIA(R) FOLATE (NO BOIL) ASSAY (K946184)Microgenics Corp.1995-01-17
CIBA CORNING ACS FOLATE ASSAY (K943297)Ciba Corning Diagnostics Corp.1994-12-12
FOLIC ACID (K943705)Diagnostic Products Corp.1994-10-31
ACCESS RED BLOOD CELL FOLATE ASSAY (K943149)Beckman Coulter, Inc.1994-08-26
QUANTAPHASE II B12/FOLATE (K935286)Bio-Rad1994-02-18
VISTA FOLATE ASSAY (K934121)Syva Co.1993-10-22
ACCESS FOLATE ASSAY (K932887)Beckman Coulter, Inc.1993-10-12
RADIAS FOLATE ENZYME IMMUNOASSAY (K933571)Bio-Rad1993-10-01
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY (K923286)Baxter Diagnostics, Inc.1992-09-17
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS (K922823)Bio-Rad Laboratories, Inc.1992-08-05
MILENIA FOLIC ACID (K921614)Diagnostic Products Corp.1992-06-25
CEDIA RED BLOOD CELL FOLATE REAGENT PACK (K921689)Microgenics Corp.1992-06-16
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY (K893684)Ciba Corning Diagnostics Corp.1989-07-27
DIAGNON FOLATE 125I RIA KIT (K841302)Diagnon Corp.1984-06-22
FOLATE RADIOASSAY KIT CA-1562-125 (K832712)Clinical Assays, Inc.1983-10-04
SOLID PHASE SIMUL TRAC VITAMIN B12 (K822728)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-11-05
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS (K812979)Amersham Corp.1981-11-24
QUANTA PHASE VITAMIN B-12/FOLATE RAD (K811177)Bio-Rad1981-05-15
MICROMEDIC SYSTEMS' AUTOPAK (K810186)Micromedic Systems1981-02-04
'NO-BOIL' DUALCOUNT KIT (K810001)Diagnostic Products Corp.1981-01-16
FOLATE 125I RADIOIMMUNOASSAY (K803060)Corning Medical & Scientific1980-12-22
FOLATE RADIOASSAY KIT (K801198)Calbiochem-Behring Corp.1980-07-21
NO-BOIL FOLATE KIT #RP-500 (K800914)Ria Products, Inc.1980-05-08
125 I FOLATE SOLID PHASE RADIOASSAY (K792167)Abbott Laboratories1979-11-13
GAMMADAB (125 1) FOLATE RADIOASSAY KIT (K791079)Clinical Assays, Inc.1979-07-17
FOLATE REAGENT KIT, ARIA-II SYSTEM (K780557)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-05-18
QUANTITOPE 125I-FOLATE RADIOASSAY KIT (K780508)Kallestad Laboratories, Inc.1978-05-03
RIA FOR FOLATES & VIT. B12, COMBO KIT (K780148)Ria Products, Inc.1978-03-03
IN VITRO FOLATE RADIOASSAY KIT (K771597)Clinical Assays, Inc.1977-09-13
RADIOASSY KIT, 3H-FOLATE (K760262)Diamond Shamrock Corp.1976-08-03
KIT, FOLATE RADIOASSAY SC.7 (K760207)Amersham Corp.1976-07-26
PROCEDURE, RED CELL FOLATE ASSAY (K760133)Bio-Rad1976-07-20

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