Atellica IM Total hCG (ThCG)— 510(k) K172322
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K172322 for Atellica IM Total hCG (ThCG), Substantially Equivalent on 2018-03-29. Applicant: Siemens Healthcare Diagnostics, Inc..
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JHI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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.