510(k) K965166 ยท JJT Enzyme Controls (Assayed And Unassayed)
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
| Applicant | Specialized Assays, Inc., Pipersville PA, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Dec 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965166
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.