STAT PROFILE M7 ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EDL ABNORMAL COAGULATION CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

ABL8X7 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPOC CHLORIDE TEST AND EPOC CREATININE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RENALYZER PRX 90

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Nova StatSensor Creatinine Hospital Meter System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CD-CHEX CD4 LOW

FDA 510(k)

FDA Class 2 ·Hematology

I-STAT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CD-CHEX

FDA 510(k)

FDA Class 2 ·Hematology

CD-CHEX PLUS BC

FDA 510(k)

FDA Class 2 ·Hematology

NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CD-CHEX CD 34

FDA 510(k)

FDA Class 2 ·Hematology

DENTO-PREP PARTICLE MICROBLASTER

FDA 510(k)

FDA Class 2 ·Dental

GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT

FDA 510(k)

FDA Class 2 ·Radiology

GL ULTRASOUND SECTOR 170

FDA 510(k)

FDA Class 2 ·Radiology

GL ULTRASOUND Z/SL 8300

FDA 510(k)

FDA Class 2 ·Radiology

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·YENNANT(TM) & KELMAN(TM) TYPE II