510(k) K974452 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VIGIL LIPID CONTROL
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Nov 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Beckman Coulter Inc Synchron Systems Hemoglobin A1c (HbA1c) Reagent Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.