TECO ISE REAGENT SET FOR CX SYSTEM— 510(k) K052724

Name: FDA 510(k) clearance K052724
Creator: U.S. Food and Drug Administration
Published: 2005-12-14

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K052724 for TECO ISE REAGENT SET FOR CX SYSTEM, Substantially Equivalent on 2005-12-14. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 2005-09-29
Decision date: 2005-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, 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.