ELECSYS T4 CALCHECK 5— 510(k) K112528

Substantially Equivalent

Roche Diagnostics Corporation

FDA 510(k) clearance K112528 for ELECSYS T4 CALCHECK 5, Substantially Equivalent on 2011-10-18. Applicant: Roche Diagnostics Corporation.

Clearance details

Applicant: Roche Diagnostics Corporation
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2011-08-31
Decision date: 2011-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.