CytoSure Urinary Access System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

FDA 510(k)

FDA Class 1 ·Microbiology

VENTRESCREEN (TM) MONO

FDA 510(k)

FDA Class 2 ·Immunology

OVOMotion Reverse Shoulder Arthroplasty System

FDA 510(k)

FDA Class 2 ·Orthopedic

LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Puritan Opti-Tranz Cary-Blair Collection and Transport System

FDA 510(k)

FDA Class 1 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT

FDA 510(k)

FDA Class 2 ·Immunology

DOCUMENT TDM ULTRA ASSAYED CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICRO SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPQ(TM) ANTIBODY REAGENT SET II FOR C4

FDA 510(k)

FDA Class 2 ·Immunology

SERIAL FLOW

FDA 510(k)

FDA Class 2 ·Anesthesiology

SHBG IRMA KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MICRO TARGETING ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAX EQUATE STREP B

FDA 510(k)

FDA Class 1 ·Microbiology