Cleared Traditional

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067

K063409 · Agamatrix · Chemistry
Jan 2007
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K063409 is an FDA 510(k) clearance for the LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Agamatrix (Salem, US). The FDA issued a Cleared decision on January 12, 2007, 60 days after receiving the submission on November 13, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K063409 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2006
Decision Date January 12, 2007
Days to Decision 60 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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