ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K122110

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K122110 for ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-11-21. Applicant: ACON Laboratories, Inc..

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2012-07-17
Decision date: 2012-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.