ISE INDIRECT NA, K, CL FOR GEN.2— 510(k) K053165

Name: FDA 510(k) clearance K053165
Creator: U.S. Food and Drug Administration
Published: 2005-12-14

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K053165 for ISE INDIRECT NA, K, CL FOR GEN.2, Substantially Equivalent on 2005-12-14. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 2005-11-14
Decision date: 2005-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.