Atellica IM Total hCG (ThCG)— 510(k) K192790

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K192790 for Atellica IM Total hCG (ThCG), Substantially Equivalent on 2019-10-30. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 2019-09-30
Decision date: 2019-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.