IMACK-MB TEST PROCEDURE (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARVIEW HCG SERUM/URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIRECTIGEN1-2-3 BHCG PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KODAK SURECELL(TM) HCG-URINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CA-1511, IN VITRO RADIOIMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VISUAL SERUM/URINE HCG COMBO KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AFFINITY HCG IMMUNIT (POLYCLONAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL UCG ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TANDEM FAST VISUAL HCG ASSAY KIT -

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BETA QUIK V

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUICKVUE ONE-STEP HCG-URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CIBA CORNING ACS HCG IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPUS(R) CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLOW-PAC CPK REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry