Cleared Special

GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM

K141829 · Ceragem Medisys, Inc. · Chemistry
Sep 2014
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K141829 is an FDA 510(k) clearance for the GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Ceragem Medisys, Inc. (Cheonan, Chungcheongnam-Do, KR). The FDA issued a Cleared decision on September 24, 2014, 79 days after receiving the submission on July 7, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K141829 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2014
Decision Date September 24, 2014
Days to Decision 79 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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