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

DUPONT LIPASE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DISPOSABLE CERVICAL BRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

DUPONT PHENOBARBITAL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology