DeviceClearance

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS— 510(k) K081478

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K081478 for RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS, Substantially Equivalent on 2008-10-06. Applicant: Bionostics, Inc..

Clearance details

Applicant
Bionostics, Inc.
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Devens, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.