TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
FDA 510(k) clearance K080269 · decided 2008-06-06
Clearance details
- K-number
- K080269
- Device name
- TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2008-02-01
- Decision date
- 2008-06-06
- Days to decision
- 126 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of cr recall (Z-1928-2012) | Alere San Diego, Inc. | 2012-07-06 |
| Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, recall (Z-1930-2012) | Alere San Diego, Inc. | 2012-07-06 |
| Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis recall (Z-1466-2012) | Alere San Diego | 2012-04-26 |
| Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of recall (Z-1467-2012) | Alere San Diego | 2012-04-26 |