TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
FDA 510(k) clearance K072892 · decided 2007-12-07
Clearance details
- K-number
- K072892
- Device name
- TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2007-10-10
- Decision date
- 2007-12-07
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- 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 Total 5 Control Level 1, Model No. 88753 Description of the product: The Tria recall (Z-0588-2017) | Alere San Diego, Inc. | 2016-11-16 |
| Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: As recall (Z-1788-2010) | Biosite Inc | 2010-06-11 |
| Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: As recall (Z-1789-2010) | Biosite Inc | 2010-06-11 |
| Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five dif recall (Z-1790-2010) | Biosite Inc | 2010-06-11 |