510(k) K101319 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
IMMULISA DSDNA ANTIBODY ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Dec 9, 2010 |
| Received | May 11, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101319
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.