FilmArray RP2/RP2plus Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

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

COMPACT TOUCH STS

FDA 510(k)

FDA Class 2 ·Radiology

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

VENTRAL WALL DEFECT REDUCTION SILO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EZTEST

FDA 510(k)

FDA Class 2 ·General Hospital

FLOWMATE LTE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SILICONE BLOCKS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TURBO-RAST SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CONTEMPRO-MIST

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICROLAB SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTREX COATED TUBE HIGH SENSITIVITY TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

FDA 510(k)

FDA Class 2 ·Orthopedic

VISIONLINK DICOM MODULE

FDA 510(k)

FDA Class 2 ·Radiology

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

FDA 510(k)

FDA Class 2 ·Clinical Toxicology