BILI-MIRROR MODEL BLM-1

FDA 510(k)

FDA Class 2 ·General Hospital

VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MICROTARGETING ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A

FDA 510(k)

FDA Class 2 ·Immunology

MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS

FDA 510(k)

FDA Class 2 ·Neurology

HI LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

STarFix Designer Software C0265

FDA 510(k)

FDA Class 2 ·Neurology

BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

BINAS LUTEINIZING HORMONE IRMA TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREX APO B

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VENTREZYME T3 IMMUNOASSAY T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FilmArray Warrior Control Panel M290

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VENTRESCREEN STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

SPQ TEST SYSTEM FOR HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology