Dna-Probe, B And T Lymphocyte

FDA Pre-Market Approval

FDA Class 2 ·ONCOR B/T GENE REARRANGEMENT TEST

Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Radioimmunoassay, Thyroxine-Binding Globulin

FDA classification

FDA Class 2 ·Radioimmunoassay, Thyroxine-Binding Globulin

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