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

URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION OF N PROTEIN STANDARD SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK

FDA 510(k)

FDA Class 2 ·Hematology