PRESAGE ST2 ASSAY
FDA 510(k) clearance K111452 · decided 2011-12-09
Clearance details
- K-number
- K111452
- Device name
- PRESAGE ST2 ASSAY
- Applicant
- Critical Care Diagnostics, Inc. (Dba Critical Diag
- Decision
- Substantially Equivalent
- Date received
- 2011-05-25
- Decision date
- 2011-12-09
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- OYG
- 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 |
|---|---|---|
| Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage recall (Z-2012-2012) | Critical Diagnostics | 2012-07-13 |