CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

INTROL CF PANEL I CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

FDA 510(k)

FDA Class 2 ·Immunology

INTROL CF PANEL I CONTROL, MODEL: G106

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

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

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