AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

E3-80 PORTABLE ECG RECORDER & ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Radioimmunoassay, Free Thyroxine

FDA classification

FDA Class 2 ·Radioimmunoassay, Free Thyroxine

Control Material, Her-2/Neu, Immunohistochemistry

FDA classification

FDA Class 2 ·Control Material, Her-2/Neu, Immunohistochemistry

System, Test, Her-2/Neu, Monitoring

FDA classification

FDA Class 2 ·System, Test, Her-2/Neu, Monitoring

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Tenaculum, Uterine, Exempt

FDA classification

FDA Class 2 ·Tenaculum, Uterine, Exempt

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MONOHAEM (FECAL OCCULT BLOOD TEST)

FDA 510(k)

FDA Class 2 ·Hematology

COUNTER 700 & HC-700 HEMO 0 REF.

FDA 510(k)

FDA Class 2 ·Hematology

LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

FDA 510(k)

FDA Class 2 ·Hematology

QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

LOW IONIC STRENGTH SOLUTION (LISS)

FDA 510(k)

FDA Class 2 ·Hematology

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN

FDA 510(k)

FDA Class 2 ·Hematology

ABNORMAL HEMOGLOBIN CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

BC-3200 AUTO HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

Cito CBC System

FDA 510(k)

FDA Class 2 ·Hematology