510(k) K895568 ยท DLJ Calibrators, Drug Specific
PRIMIDONE (FPIA) CALIBRATOR KIT
| Applicant | Tudor Laboratories, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Sep 28, 1989 |
| Received | Sep 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895568
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.