510(k) K901900 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
L.D.X LIPID MONITORING SYSTEM
| Applicant | Cholestech Corp., Hayward CA, US |
| Decision | Substantially Equivalent, Jul 24, 1990 |
| Received | Apr 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2012 | Alere San Diego Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic. Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.