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CKA — Nadh Oxidation/Nad Reduction, Alt/Sgpt Class I

FDA Device Classification

Classification Details

Product Code
CKA
Device Class
Class I
Regulation Number
862.1030
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K120945hitachi chemical diagnosticsHITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZEJune 7, 2013
K113382alfa wassermannACE ALT REAGENTJuly 19, 2012
K061020dade behringDIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBMay 10, 2006
K020487caresideCARESIDE ALTJune 4, 2002
K980028trace americaALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY February 2, 1998
K973869trace americaTRACE REAGENT LINE FOR THE COBAS MIRAJanuary 7, 1998
K974003diagnostic chemicalsALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30December 5, 1997
K971323carolina liquid chemistriesALT OR SGPTApril 21, 1997
K965134derma media labALT/SGPTFebruary 18, 1997
K961123trace scientificALT INCORPORATING DSTApril 25, 1996
K952427beckman instrumentsCX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSeptember 21, 1995
K952744medical diagnostic technologiesALANINE AMINOTRANSFERASE REAGENT SYSTEMAugust 7, 1995
K951332dade intlPARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENTJune 19, 1995
K951818hi chemHICHEM ALT REAGENT KITMay 15, 1995
K944080prisma systemsALT QVETNovember 22, 1994
K941314stanbio laboratorySTANBIO ALT/GPT (LUQUI-UV) TEST SETJuly 20, 1994
K941497solarcareSOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAYMay 24, 1994
K941287pointe scientific, incLIQUID ALT(SGPT) REAGENT SETMay 3, 1994
K935180em diagnostic systemsALANINE AMINOTRANSFERASE (ALT) TESTJanuary 13, 1994
K930070isolabHEMOCARD HEMOGLOBIN EApril 8, 1993