510(k) K861770 ยท JIS Calibrator, Primary
PHENYTOIN (FPIA) CALIBRATOR KIT
| Applicant | Windsor Laboratories, Inc., Garland TX, US |
| Decision | Substantially Equivalent, Jun 25, 1986 |
| Received | May 7, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861770
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.