ADVIA Centaur High-Sensitivity Troponin I (TNIH)— 510(k) K171274
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K171274 for ADVIA Centaur High-Sensitivity Troponin I (TNIH), Substantially Equivalent on 2018-07-12. Applicant: Siemens Healthcare Diagnostics, Inc..
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code MMI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Adverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.