510(k) K911679 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ANTI-JO-1 MICROASSAY
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Sep 23, 1991 |
| Received | Apr 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911679
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.