510(k) K945337 ยท DLJ Calibrators, Drug Specific
PHENYTOIN CALIBRATORS
| Applicant | Diagnostic Reagents, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 7, 1994 |
| Received | Nov 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945337
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.