MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3— 510(k) K012430

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K012430 for MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3, Substantially Equivalent on 2001-08-27. Applicant: Bionostics, Inc..

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2001-07-31
Decision date: 2001-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, 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.