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 AMMONIA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 1 ·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

DIMENSION(R) LACTIC ACID METHOD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OCIDE HOSPITAL CLEANER-DISINFECTANT

FDA 510(k)

FDA Class 1 ·General Hospital

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

DIMENSION EXL WITH LM SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TGL FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DU PONT COMPACT DAYLIGHT SYSTEM 2000

FDA 510(k)

FDA Class 2 ·Radiology