WAYPOINT STEREOTACTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

FilmArray RP2/RP2plus Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SUPER-SIL

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology

DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRANSPORT CULTURE MEDIUM DEVICE

FDA 510(k)

FDA Class 1 ·Microbiology

VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT ENZYME

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

ALERE I INFLUENZA A & B

FDA 510(k)

FDA Class 2 ·Microbiology

ACTIVEECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLOWMATE LTE

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTREZYME ALLERGEN DATA REDUCTION SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ALERE BINAXNOW INFLUENZA A & B CARD

FDA 510(k)

FDA Class 1 ·Microbiology

DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK

FDA 510(k)

FDA Class 1 ·Microbiology

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

URASSIST

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology