Medical Device Manufacturer · US , Frederick , MD

Eurodiagnostica - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2005

Recent clearances: IMMUNOSCAN RA ANTI-CCP TEST SYSTEM, WIESLAB CAP MPO-ANCA, WIESLAB CAP PR-3 ANCA

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Eurodiagnostica Immunology ✕

3 devices

1-3 of 3

Cleared Dec 12, 2005

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

Immunology · 129d

Cleared Nov 23, 2005

WIESLAB CAP MPO-ANCA

Immunology · 174d

Cleared Nov 22, 2005

WIESLAB CAP PR-3 ANCA

Immunology · 173d