CLEARIUM, MOUNTING MEDIUM

FDA 510(k)

FDA Class 1 ·Pathology

ENTELLAN

FDA 510(k)

FDA Class 1 ·Pathology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Fortify, Fortify Assura, Ellipse

ANTIASTHMATIC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MONITORX LASERX THEOPHYLLINE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SODIUM AND POTASSIUM BY ION SELECTIVE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

FDA 510(k)

FDA Class 2 ·Microbiology

THERAPEUTIC DRUG MONITORING CONTROL SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

FDA 510(k)

FDA Class 2 ·Hematology

ENZYMATIC CO2 REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETHANOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DURAZYME(R) CPK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry