ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CHEMISTRY MICROALBUMIN CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIPOPROTEIN FOR MULTIPLE ANALYTES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SETPOINT CHEMISTRY CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

FDA 510(k)

FDA Class 2 ·Hematology

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CONTOUR NEXT BLOOD GLUCOSE METER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)

FDA 510(k)

FDA Class 2 ·Neurology

BAYER CLINITEK STATUS ANALYZER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIPOPROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLINITEK ADVANTUS, MODEL 1420

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER ADVIA CENTAUR CA 19-9 ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA IMS VALPROIC ACID METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIDGET WORLD REPORTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER SPECIFIC PROTEIN REFERENCE SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry