510(k) K040579 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
| Applicant | Cholestech Corp., Hayward CA, US |
| Decision | Substantially Equivalent, Jun 18, 2004 |
| Received | Mar 4, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040579
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2013 | Alere San Diego, Inc. The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807.
Product Usage:
Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Ch Terminated |
DCK | None listed |
| Sep 20, 2008 | Cholestech Corp Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determin Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.