510(k) K010358 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VIGIL SEROLOGY CONTROL LEVEL C
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Mar 5, 2001 |
| Received | Feb 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010358
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.