SPIROMETRICS MODEL 2600 MIRO SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

WAYPOINT STEREOTACTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

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

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

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

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

VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology