510(k) K070709— ROCHE ELECSYS PTH TEST SYSTEM

Substantially Equivalent

Roche Diagnostics Corp.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2007-03-14
Decision date: 2007-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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.