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

Substantially Equivalent

Corning Medical & Scientific

Clearance details

Applicant
Corning Medical & Scientific
Product code
Code JGS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Medfield, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JGS

product code JGS
Malfunction
535
Total
535

Source: openFDA MAUDE database, through . 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.