510(k) K013235 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MODIFICATION TO SYNCHRON CONTROL
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Oct 16, 2001 |
| Received | Sep 28, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2004 | Beckman Coulter Inc Synchron Liquid Comprehensive Chemistry Control Serum.
Part numbers: 660710, 657365. Terminated |
LEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.