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

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

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

VENTREZYME T3 IMMUNOASSAY T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FilmArray Warrior Control Panel M290

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPQ TEST SYSTEM FOR HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTREX COATED TUBE TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ID NOW Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX COATED TUBE INTACT PTH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry