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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

FDA classification

FDA Class 2 ·Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

E3-80 PORTABLE ECG RECORDER & ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Alpha-2-Macroglobulin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Alpha-2-Macroglobulin, Antigen, Antiserum, Control

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

Colposcope (And Colpomicroscope), Exempt

FDA classification

FDA Class 2 ·Colposcope (And Colpomicroscope), Exempt

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

THROMBONOSTIKA F1.2

FDA 510(k)

FDA Class 2 ·Hematology

PLASMA THERAPY TUBESET-E100 SERIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology