TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD— 510(k) K895672

Name: FDA 510(k) clearance K895672
Creator: U.S. Food and Drug Administration
Published: 1989-10-25

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K895672 for TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD, Substantially Equivalent on 1989-10-25. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1989-09-20
Decision date: 1989-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.