510(k) K001458 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
SYNCHRON CONTROL
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 2, 2000 |
| Received | May 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001458
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.