TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
FDA 510(k) clearance K030286 · decided 2003-02-21
Clearance details
- K-number
- K030286
- Device name
- TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2003-01-28
- Decision date
- 2003-02-21
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Tropon recall (Z-1974-2023) | QUIDEL CARDIOVASCULAR INC | 2023-07-07 |
| Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine recall (Z-1929-2012) | Alere San Diego, Inc. | 2012-07-06 |
| Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a recall (Z-1391-2009) | Biosite Inc | 2009-05-08 |