510(k) K940229 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
SYN ENA SCREEN (PIN PLATE)
| Applicant | Elias U.S.A., Inc., Osceola WI, US |
| Decision | Substantially Equivalent, May 11, 1994 |
| Received | Jan 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940229
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.