Medical Device Manufacturer · US , Edison , NJ

Technidyne Corp. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1993

Recent clearances: HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION, HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Technidyne Corp. Hematology ✕

2 devices

1-2 of 2

Cleared Sep 02, 1993

HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION

Hematology · 239d

Cleared Sep 02, 1993

HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY

Hematology · 240d