510(k) K944698 ยท CFT Radioimmunoassay, Prolactin (Lactogen)
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Mar 21, 1995 |
| Received | Sep 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944698
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.