510(k) K002196 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 7, 2000 |
| Received | Jul 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002196
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.