DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL #510GE1500 LIVER ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

INTROL CF PANEL I CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

FDA 510(k)

FDA Class 2 ·Immunology

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

INTROL CF PANEL I CONTROL, MODEL: G106

FDA 510(k)

FDA Class 2 ·Microbiology

PARA 12 PLUS RETICS

FDA 510(k)

FDA Class 2 ·Hematology

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BRUSHRITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

XN CHECK

FDA 510(k)

FDA Class 2 ·Hematology

XN CAL PF

FDA 510(k)

FDA Class 2 ·Hematology

PARA 12 PLUS

FDA 510(k)

FDA Class 2 ·Hematology