ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
FDA 510(k) clearance K051752 · decided 2005-07-11
Clearance details
- K-number
- K051752
- Device name
- ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2005-06-29
- Decision date
- 2005-07-11
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
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