510(k) K850480 ยท CEP Radioimmunoassay, Luteinizing Hormone
OVU STICK SELF-TEST -MODIFICATION
| Applicant | Monoclonal Antibodies, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 5, 1985 |
| Received | Jan 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850480
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.