AVL #980 ELECTROLYTE ANALYZER— 510(k) K801011

Substantially Equivalent

Gauntlet Technology Corp.

FDA 510(k) clearance K801011 for AVL #980 ELECTROLYTE ANALYZER, Substantially Equivalent on 1980-07-08. Applicant: Gauntlet Technology Corp..

Clearance details

Applicant: Gauntlet Technology Corp.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1980-04-25
Decision date: 1980-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.