ELECSYS TROPONIN T STAT TEST
FDA 510(k) clearance K040733 · decided 2004-05-17
Clearance details
- K-number
- K040733
- Device name
- ELECSYS TROPONIN T STAT TEST
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-22
- Decision date
- 2004-05-17
- Days to decision
- 56 days
- Clearance type
- Traditional
- 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-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
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| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
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