SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
FDA 510(k) clearance K051114 · decided 2005-11-25
Clearance details
- K-number
- K051114
- Device name
- SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
- Applicant
- Sentinel Ch. Srl
- Decision
- Substantially Equivalent
- Date received
- 2005-05-02
- Decision date
- 2005-11-25
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- JIF
- Device class
- 1
- Regulation number
- 862.1065
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milano, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; Lis recall (Z-0164-2016) | Sentinel CH SpA | 2015-10-26 |