510(k) K010748 ยท LCP Assay, Glycosylated Hemoglobin
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jul 10, 2001 |
| Received | Mar 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010748
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2004 | Beckman Coulter Inc Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent
Part No.: 469905 Lot M206161 (level 1)
Part No.: 465980 Lot M206192 (level 2)
Part No.: 465982 Lot M206194 (level 4)
Part No. Terminated |
MRR | None listed |
| Jul 23, 2004 | Beckman Coulter Inc Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent. Terminated |
MSS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.