AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION— 510(k) K121654

Substantially Equivalent

I-Sens, Inc.

FDA 510(k) clearance K121654 for AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION, Substantially Equivalent on 2012-09-05. Applicant: I-Sens, Inc..

Clearance details

Applicant: I-Sens, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2012-06-05
Decision date: 2012-09-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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.