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CGN — Acid, Folic, Radioimmunoassay Class II

FDA Device Classification

Classification Details

Product Code
CGN
Device Class
Class II
Regulation Number
862.1295
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233060roche diagnosticsElecsys Folate IIIJune 17, 2024
K223590beckman coulterAccess Folate AssayAugust 23, 2023
K192586diasorinLIAISON® FolateMay 6, 2020
K172201siemens healthcare diagnosticsAtellica IM Folate AssayApril 12, 2018
K161646diazyme laboratoriesDiazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetNovember 4, 2016
K141426roche diagnosticsELECSYS FOLATE IIIOctober 17, 2014
K103716roche diagnosticsROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSETMay 12, 2011
K092740abbott laboratoriesARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE COMarch 5, 2010
K091332tosoh bioscienceAIA-PACK RBC FOLATEOctober 2, 2009
K082340roche diagnosticsROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELEJune 19, 2009
K060774beckman coulterFOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208April 21, 2006
K051292roche diagnosticsELECSYS RBC FOLATE HEMOLYZED REAGENTJune 17, 2005
K043318roche diagnosticsMODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAYDecember 23, 2004
K031756roche diagnosticsROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAYJune 25, 2003
K023397abbott laboratoriesABBOTT ARCHITECT FOLATEDecember 16, 2002
K010050bayer diagnosticsADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAYFebruary 5, 2001
K001266ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAMay 2, 2000
K993254diagnostic productsIMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06November 12, 1999
K992365tosoh medicsAIA-PACK FOLATE ASSAYAugust 10, 1999
K991582chiron diagnosticsCHIRON DIAGNOSTICS ACS: 180 FOLATEJune 30, 1999