MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DADE TRU-LIQUID BILIRUBIN CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CHEMSPEX(TM) AMMONIA CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CONTREX PLUS LOW CONTROL SOLUTION

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DAC-CEL DIAGNATAL HCG STANDARDS RD49

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Multichem A1c

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELECSYS CK-MB CALCHECK 5

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OPUS T4 CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELECSYS RUBELLA IGGA CALCHECK 5

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUISPEX URINE (MICRO)ALBUMIN CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMULITE HCG HIGH LEVEL CONTROL MODULE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry