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

STRATUS CS MYO CALPAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension Vista MMB Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

OPUS TROPONIN I (CTN) TEST MODULES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry