TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL— 510(k) K030286
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K030286 for TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL, Substantially Equivalent on 2003-02-21. 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
- Special
- Location
- San Diego, CA, US
Recent devices under product code NBC
view allMore clearances from Biosite Incorporated
view allRecalls naming K030286
K-number listed on FDA's recall record- Z-1974-2023 — Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
- Z-1929-2012 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030286.
Data sourced from openFDA. This site is unofficial and independent of the FDA.