NSI SODIUM/POTASSIUM KIT— 510(k) K800584

Substantially Equivalent

Nobel Scientific Industries, Inc.

FDA 510(k) clearance K800584 for NSI SODIUM/POTASSIUM KIT, Substantially Equivalent on 1980-04-02. Applicant: Nobel Scientific Industries, Inc..

Clearance details

Applicant
Nobel Scientific Industries, Inc.
Product code
Code JGS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, 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.