510(k) K042335 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
| Applicant | Bio-Rad Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 17, 2004 |
| Received | Aug 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042335
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.