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JKC — Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Class I

FDA Device Classification

Classification Details

Product Code
JKC
Device Class
Class I
Regulation Number
862.1245
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K040181beckman coulterACCESS DHEA-S REAGENT ASSAYMarch 24, 2004
K003174roche diagnosticsELECSYS DHEA-SJanuary 17, 2001
K973897kmi diagnosticsDHEA-SNovember 13, 1997
K962895diagnostic systems laboratoriesDSL DHEA-S-7September 10, 1996
K955114diagnostic systems laboratoriesDSL AACTIVE DHEA EIA KITFebruary 23, 1996
K950524nichols instituteNICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYMay 15, 1995
K942051serono diagnosticsSR1 DHEA-S ENZYME IMMUNOASSAYJuly 13, 1994
K935014diagnostic systems laboratoriesACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)May 9, 1994
K935806diagnostic productsIMMULITE DHEA-S04April 26, 1994
K935469elias u.s.aSYNELISA DHEA-SULFATEMarch 22, 1994
K931601nichols instituteCHEMILUMINESCENCE DHEA-S IMMUNOASSAYJuly 27, 1993
K903616diagnostic systems laboratoriesDSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)September 10, 1990
K891478diagnostic systems laboratoriesDSL 7900 ACTIVE DHEA-S (DSL #7900)April 26, 1989
K872879endocrine associatesDHEA-S RIA KITOctober 23, 1987
K853867pantex, div. bio-analysisPANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAYOctober 4, 1985
K852847diagnostic productsSOPHEIA DHEA-SO4 EIA KITAugust 2, 1985
K851239diagnostic systems laboratoriesACTIVE DHEA-SULFATE DSL3500April 25, 1985
K843635cambridge medical technologyMATCHED COMPONENT SET FOR RADIOIMMUNO-September 28, 1984
K842606diagnostic productsCOAT-A-COUNT DHEA RIA KITAugust 17, 1984
K842552diagnostic productsCOAT-A-COUNT DHEA-SO4 RIA KITAugust 17, 1984