CORNING 614 NA/K ANALYZER— 510(k) K843530

Name: FDA 510(k) clearance K843530
Creator: U.S. Food and Drug Administration
Published: 1984-12-11

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K843530 for CORNING 614 NA/K ANALYZER, Substantially Equivalent on 1984-12-11. Applicant: Corning Medical & Scientific. Device class: 2.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Product code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1984-09-07
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, 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.