510(k) K953671 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
ORGEN TEC ANTI-DSDNA ELISA ASSAY
| Applicant | Orgentec, Windham NH, US |
| Decision | Substantially Equivalent, Nov 9, 1995 |
| Received | Aug 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953671
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.