510(k) K971505 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 11, 1997 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2021 | Beckman Coulter Inc. SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 Open, Classified |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.