SPQ(TM) TEST SYSTEM FOR PREALBUMIN

FDA 510(k)

FDA Class 1 ·Immunology

VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TRANSPORT CULTURE MEDIUM DEVICE

FDA 510(k)

FDA Class 1 ·Microbiology

BINAX PROLACTIN IRMA DIAGNOSTIC KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AHAC ITE MODEL ENTENDRE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPQ(TM) TEST SYSTEM FOR MICROALBUMIN

FDA 510(k)

FDA Class 1 ·Immunology

DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT CHEM III CALIBRATION VERIFICATION TEST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FACEPLATE ASSEMBLY

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

VISIONLINK INTERFILE CONVERSION SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

SPECIFIC IGE EIA-TURBO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry