ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELITech Clinical Systems CALCIUM ARSENAZO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assure Prism multi Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ReliOn Premier Classic Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CareSens S Clear BT Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CareSens S Fit BT Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ReliOn Premier BLU Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIVE AND SHALLOW AND GRAND DIVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CareSens S Fit Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry