510(k) K030286 ยท NBC Test, Natriuretic Peptide
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Feb 21, 2003 |
| Received | Jan 28, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2023 | QUIDEL CARDIOVASCULAR INC Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045. Open, Classified |
MMI | None listed |
| Jul 6, 2012 | Alere San Diego, Inc. Alere Triage Cardiac Panel PN 97000HS
Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. Terminated |
NBC | None listed |
| May 8, 2009 | Biosite Inc Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box.
Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determi Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.