510(k) K942443 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
AURAFLEX SYSTEMS
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Aug 26, 1994 |
| Received | May 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942443
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.