510(k) K113143 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
IMMULISA SCI-70 ANTIBODY ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Dec 2, 2011 |
| Received | Oct 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113143
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.