510(k) K080294 ยท NAK System, Test, Biotinidase
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
| Applicant | Astoria-Pacific, Inc., Clackamas OR, US |
| Decision | Substantially Equivalent, Nov 4, 2008 |
| Received | Feb 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080294
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.