Cleared Special

WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM

K073573 · Agamatrix · Chemistry
Jan 2008
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K073573 is an FDA 510(k) clearance for the WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM, 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 30, 2008, 41 days after receiving the submission on December 20, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K073573 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2007
Decision Date January 30, 2008
Days to Decision 41 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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