Elecsys PTH , Elecsys PTH STAT— 510(k) K231927

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K231927 for Elecsys PTH , Elecsys PTH STAT, Substantially Equivalent on 2024-03-22. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2023-06-30
Decision date: 2024-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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.