REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

LUPO-TEC

FDA 510(k)

FDA Class 2 ·Immunology

SYSTEMIC LUPUS

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNO/SLE

FDA 510(k)

FDA Class 2 ·Immunology

VCS S3Y

FDA 510(k)

FDA Class 2 ·Physical Medicine

VCS S3T

FDA 510(k)

FDA Class 2 ·Physical Medicine

VCS, MODEL S4T

FDA 510(k)

FDA Class 2 ·Physical Medicine

NOVA CO-OXIMETER ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

NDX DORSAL APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endotoxin Activity Assay (EAA)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·COOK MBC PTCA BALLOON DILATATION CATHETER