ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY— 510(k) K121981

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K121981 for ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY, Substantially Equivalent on 2013-03-21. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2012-07-06
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.