DUPONT ACA URINE METHADONE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT II PLUS COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CONTROL PLASMA N, PROC CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHENYTOIN ACA ANALYTICAL TEST PACK

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LABELING CHANGE - VIASPAN(TM) (BELZER UW)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDIAC TROPONIN-I (TROP) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MMB METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA URINE DRUGS OF ABUSE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

FDA 510(k)

FDA Class 2 ·Hematology