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CFJ — Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Class II

FDA Device Classification

Classification Details

Product Code
CFJ
Device Class
Class II
Regulation Number
862.1440
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K131975alfa wassermann diagnostic technologiesACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, AOctober 2, 2013
K091544alfa wassermannS-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017September 9, 2009
K051108abaxisPICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMJuly 8, 2005
K974859diagnostic chemicalsLACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30January 22, 1998
K973589pointe scientific, incLIQUID LDH-L REAGENT SETOctober 8, 1997
K970684randox laboratoriesLACTATE DEHYDROGENASE (LD)May 7, 1997
K971398carolina liquid chemistriesLD-L REAGENTMay 2, 1997
K964912derma media labLACTATE DEHYDROGENASEJanuary 9, 1997
K961431pointe scientific, incLACTATE DEHYDROGENASE REAGENT SETJune 3, 1996
K952747medical diagnostic technologiesLACTATE DEHYDROGENASE REAGENT SYSTEMAugust 7, 1995
K946022hichem diagnosticsHICHEM LDH/L REAGENT KITFebruary 23, 1995
K942964prisma systemsLACTATE DEHYDROGENASE QVETDecember 29, 1994
K935175em diagnostic systemsLACTATE DEHYDROGENASE (LD)December 16, 1993
K924703em diagnostic systemsLACTATE DEHYDROGENASE (LD) TEST ITEM #65418February 5, 1993
K924965olympusOLYMPUS LACTATE DEHYDROGENASE REAGENTNovember 16, 1992
K923412olympusOLYMPUS LACTATE DEHYDROGENASE REAGENTSeptember 18, 1992
K921025synermedSYNERMED LDHH-L REAGENT KITMarch 23, 1992
K915803data medical associatesDMA LD KINETIC PROCEDUREMarch 18, 1992
K914262em diagnostic systemsABBOTT QUICKSTART LDH,#5A31October 11, 1991
K910640em diagnostic systemsSYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476April 12, 1991