510(k) K112603 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Nov 4, 2011 |
| Received | Sep 7, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K112603
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.