510(k) K951320 ยท JNL Immunochemical, Thyroglobulin Autoantibody
AURAFLEX TG-AB AND TPO-AB
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Aug 25, 1995 |
| Received | Mar 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951320
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.