510(k) K896868 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
OPUS PHENYTOIN TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jan 2, 1990 |
| Received | Dec 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896868
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.