Wieslab AB
Frederick, MD, US
Wieslab AB appears in FDA device records in Frederick, MD. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Wieslab AB in 1998.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981750 | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM | MOB | Substantially Equivalent | |
| K981748 | WIELISA ANCA SCREENING KIT TEST SYSTEM | MOB | Substantially Equivalent | |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | DBL | Substantially Equivalent | |
| K974167 | WIELISA PR-3 ANCA TEST SYSTEM | MOB | Substantially Equivalent | |
| K974166 | WIELISA MPO ANCA TEST SYSTEM | MOB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain