510(k) K983578 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 12, 1998 |
| Received | Oct 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983578
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.