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CIZ — Radioimmunoassay, Androstenedione Class I

FDA Device Classification

Classification Details

Product Code
CIZ
Device Class
Class I
Regulation Number
862.1075
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K963002diagnostic systems laboratoriesACTIVE ANDROSTENEDIONE EIAAugust 16, 1996
K954755diagnostic productsCOAT-A-COUNT DIRECT ANDROSTENEDIONENovember 29, 1995
K934751diagnostic systems laboratoriesACTIVE ANDROSTANEDIOL GLUCURONIDEJanuary 10, 1994
K860559immuchemANDROSTENEDIONE 125I KIT BY RIAMarch 14, 1986
K854673diagnostic systems laboratoriesDSL ANDROSTENEDIONE RIA (DSL # 4200)January 22, 1986
K854650diagnostic systems laboratoriesDSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)December 13, 1985
K844398diagnostic productsCOAT-A-COUNT ANDROSTENEDIONE RIA KITDecember 10, 1984
K842960radioassay systems laboratoriesANDROSTENEDIONE BY RIASeptember 27, 1984
K832452wien laboratoriesANDROSTENEDIONE TEST SET 125ISeptember 12, 1983
K801729diagnostics biochem canadaANDROSTENEDIONE RADIOIMMUNOASSAY KITOctober 31, 1980