510(k) K983807 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 16, 1998 |
| Received | Oct 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983807
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.