SYSMEX AUTOMATED COAGULATION ANALYZER CA-500

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRONEX REGULAR CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT C-REACTIVE PROTEIN (CRP) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N APOLIPOPROTEIN STANDARD SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

FDA 510(k)

FDA Class 2 ·Immunology

CONTROL PLASMA N AND CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BWF-5 MEDICAL LASER SERIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT DRUG CLIBRATOR-B

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION C4 FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology