510(k) K072892 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Oct 10, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2020 | Medline Industries Inc Control, Calibrator Verified, Triage BNP, Model ALR88755 Terminated |
JJY | None listed |
| Nov 16, 2016 | Alere San Diego, Inc. Alere Triage Total 5 Control Level 1, Model No. 88753
Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test p Terminated |
JJY | None listed |
| Jun 11, 2010 | Biosite Inc Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C.
Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Tes Terminated |
JJY | None listed |
| Jun 11, 2010 | Biosite Inc Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C.
Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Terminated |
JJY | None listed |
| Jun 11, 2010 | Biosite Inc Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C.
Intended use: Materials used with the Triage Profiler S.O. Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.