510(k) K922241 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
AUTOZYME
| Applicant | Cambridge Life Sciences Plc., Great Neck NY, US |
| Decision | Substantially Equivalent, Nov 30, 1992 |
| Received | May 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922241
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.