ELECSYS T3 CALCHECK 5— 510(k) K111552

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K111552 for ELECSYS T3 CALCHECK 5, Substantially Equivalent on 2011-07-21. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2011-06-03
Decision date: 2011-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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.