DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO STANDARD HUMAN PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SYVA EMIT II PLUS AMPHETAMINES ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT GENTAMICIN ASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ISOTYPES HUMAN IGG SUBCLASS EIA KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605

FDA 510(k)

FDA Class 2 ·Immunology

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