DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENZYGNOST F+2 (MONOCLONAL) TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

N ANTISERA TO HUMAN TRANSFERRIN

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CC-Clip® Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology

BWF-5 MEDICAL LASER SERIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANALYST ANALYTICAL TEST ROTORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH Diazo Total Bilirubin (D_TBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry