510(k) K944846 ยท JZG System, Test, Beta-2-Microglobulin Immunological
AURAFLEX B2-MICROGLOBULIN
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jun 20, 1995 |
| Received | Sep 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944846
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.