510(k) K010844 ยท NAK System, Test, Biotinidase
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
| Applicant | Astoria-Pacific, Inc., Clakamas OR, US |
| Decision | Substantially Equivalent, Sep 21, 2001 |
| Received | Mar 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010844
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.