TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ALERE INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENTR AMMONIA/ETHANOLCALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR COMPLEMENT C4

FDA 510(k)

FDA Class 2 ·Immunology

DOCUMENT CK ISOENZYMES CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPIROMETRICS MODEL 2600 MIRO SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT(R) ZERO

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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