PSA CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELECSYS CALCHECK PSA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

THIRD GENERATION PSA CONTROL MODULE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS HYBRITECH PSA QC, MODEL 37209

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FASTPACK TOTAL PSA METHOD VERIFICATION KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMULITE PSA CONTROL MODULE, MODEL LPSCM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS HYBRITECH FREE PSA QC, MODEL 37219

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT IMX TOTAL PSA

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT ARCHITECT TOTAL PSA

IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT

FDA 510(k)

FDA Class 1 ·Pathology

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

NEUROCHEMICAL ANALYZER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ESA PLASMA FREE METANEPHRINE ANALYSIS KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry