ADVIA CENTAUR TSH3-ULTRA METHOD— 510(k) K083844
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K083844 for ADVIA CENTAUR TSH3-ULTRA METHOD, Substantially Equivalent on 2009-05-08. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code JLW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Adverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
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.