510(k) K950028 ยท LFT Fluorescent Immunoassay, Primidone
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 21, 1995 |
| Received | Jan 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950028
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.