Cleared Traditional

CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM

K131727 · Ceragem Medisys, Inc. · Chemistry
Feb 2014
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K131727 is an FDA 510(k) clearance for the CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Ceragem Medisys, Inc. (Cheonan Si, Chungcheongnam-Do, KR). The FDA issued a Cleared decision on February 28, 2014, 261 days after receiving the submission on June 12, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K131727 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2013
Decision Date February 28, 2014
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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