FDA 510(k) Applications for Medical Device Product Code "CIZ"
(Radioimmunoassay, Androstenedione)

FDA 510(k) Number Applicant Device Name Decision Date
K844398 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT ANDROSTENEDIONE RIA KIT 12/10/1984
K954755 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT DIRECT ANDROSTENEDIONE 11/29/1995
K934751 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE ANDROSTANEDIOL GLUCURONIDE 01/10/1994
K963002 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE ANDROSTENEDIONE EIA 08/16/1996
K854650 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) 12/13/1985
K854673 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ANDROSTENEDIONE RIA (DSL # 4200) 01/22/1986
K801729 DIAGNOSTICS BIOCHEM CANADA, INC. ANDROSTENEDIONE RADIOIMMUNOASSAY KIT 10/31/1980
K860559 IMMUCHEM CORP. ANDROSTENEDIONE 125I KIT BY RIA 03/14/1986
K842960 RADIOASSAY SYSTEMS LABORATORIES, INC. ANDROSTENEDIONE BY RIA 09/27/1984
K832452 WIEN LABORATORIES, INC. ANDROSTENEDIONE TEST SET 125I 09/12/1983


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