DOCUMENT ENZYME LINEARITY TEST SETS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

FLIPSCREEN (TM) TOTAL E IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE Heparin Calibration Verification/Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO DOCUMENT THYROID CAL.VER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

FDA 510(k)

FDA Class 2 ·General Hospital

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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