CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K131727

Substantially Equivalent

Ceragem Medisys, Inc.

FDA 510(k) clearance K131727 for CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2014-02-28. Applicant: Ceragem Medisys, Inc..

Clearance details

Applicant: Ceragem Medisys, Inc.
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2013-06-12
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheonan Si, Chungcheongnam-Do, KR

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Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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.