510(k) K882340 ยท CEP Radioimmunoassay, Luteinizing Hormone
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Aug 8, 1988 |
| Received | Jun 7, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882340
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.