510(k) K873708 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
| Applicant | Whittaker Bioproducts, Inc., Walkersville MD, US |
| Decision | Substantially Equivalent, Nov 25, 1987 |
| Received | Sep 15, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873708
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.