N LATEX STFR REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

Plus Surgical Drapes (EO Sterilized), PMDB-XXX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUART ARTERIAL FILTER, MODEL HBF 140

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HERPTRAN CONCENTRATE

FDA 510(k)

FDA Class 2 ·Microbiology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

THYROID CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA VANCOMYCIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRONEX RADIATION THERAPY CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CAPOGEN Laser Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology