Cleared Traditional

LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

K102751 · Ceragem Medisys, Inc. · Chemistry
Feb 2013
Decision
872d
Days
Class 2
Risk

About This 510(k) Submission

K102751 is an FDA 510(k) clearance for the LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Ceragem Medisys, Inc. (Los Angeles, US). The FDA issued a Cleared decision on February 11, 2013, 872 days after receiving the submission on September 23, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K102751 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2010
Decision Date February 11, 2013
Days to Decision 872 days
Submission Type Traditional
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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