510(k) K801928 ยท JWL Antigen, Treponema Pallidum For Fta-Abs Test
LAB-TEK FTA-ABS KIT
| Applicant | Miles Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 20, 1980 |
| Received | Aug 12, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801928
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.