510(k) K080269 ยท NBC Test, Natriuretic Peptide
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 6, 2008 |
| Received | Feb 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080269
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Alere San Diego, Inc. Alere Triage CardioProfiler Panel PN 97100CP
Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and Terminated |
NBC | None listed |
| Jul 6, 2012 | Alere San Diego, Inc. Alere Triage Profiler SOB Panel PN 97300
Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D Terminated |
DAP | None listed |
| Apr 26, 2012 | Alere San Diego Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart fai Terminated |
MMI | None listed |
| Apr 26, 2012 | Alere San Diego Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.