510(k) K014103 ยท MRR System, Test, Low Density, Lipoprotein
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jan 28, 2002 |
| Received | Dec 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014103
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Beckman Coulter Inc LDL Cholesterol Reagent (LDLD)
Part No. 969706 Terminated |
MRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.