RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4— 510(k) K021624

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K021624 for RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4, Substantially Equivalent on 2002-07-12. Applicant: Bionostics, Inc..

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2002-05-16
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Devens, MA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.