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

DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD

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

LINX NETWORKING SYSTEM

FDA 510(k)

FDA Class 1 ·Radiology

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMIT-AMD AMIKACIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology