510(k) K010428 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 13, 2001 |
| Received | Feb 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010428
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.