TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS— 510(k) K080269
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K080269 for TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS, Substantially Equivalent on 2008-06-06. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code NBC
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- K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
- K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
- K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
- K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
Recalls naming K080269
K-number listed on FDA's recall record- Z-1928-2012 — 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 plasma specimens.
- Z-1930-2012 — 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-dimer in EDTA anticoagulated whole blood and plasma specimens.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080269.
Data sourced from openFDA. This site is unofficial and independent of the FDA.