Medical Device Manufacturer · US , Frederick , MD

Wieslab AB - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1998

Recent clearances: WIELISA ANCA SCREENING KIT TEST SYSTEM, WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM, WIELISA MPO ANCA TEST SYSTEM

View 5 510(k) Devices ↓
5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Wieslab AB Immunology ✕

5 devices
1-5 of 5
Cleared Jul 22, 1998
WIELISA ANCA SCREENING KIT TEST SYSTEM
K981748 · MOB
Immunology · 65d
Cleared Jul 22, 1998
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
K981750 · MOB
Immunology · 65d
Cleared Feb 17, 1998
WIELISA MPO ANCA TEST SYSTEM
K974166 · MOB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA PR-3 ANCA TEST SYSTEM
K974167 · MOB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA ANTI-GBM TEST SYSTEM
K974169 · DBL
Immunology · 104d
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