Nova Primary Glucose Analyzer System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CO/CMD-1

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FLOWMATE II PLUS, MODEL #4000

FDA 510(k)

FDA Class 2 ·Anesthesiology

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VENTREX COATED TUBE HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BRIGHT EMBRACE MODEL SBL60

FDA 510(k)

FDA Class 2 ·General Hospital

MICROTARGETING GUIDELINE 4000

FDA 510(k)

FDA Class 2 ·Neurology

VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPQ TM TEST SYSTEM II FOR CRP

FDA 510(k)

FDA Class 2 ·Immunology

HBM HEMOGLOBINOMETER

FDA 510(k)

FDA Class 2 ·Hematology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

BINAX STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology