510(k) K970905 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 4, 1997 |
| Received | Mar 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2004 | Beckman Coulter Inc SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465 Terminated |
CHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.