Cleared Special

WaveSense Jazz Blood Glucose Monitoring System

K241304 · Agamatrix · Chemistry
Jun 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241304 is an FDA 510(k) clearance for the WaveSense Jazz 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 June 6, 2024, 28 days after receiving the submission on May 9, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K241304 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2024
Decision Date June 06, 2024
Days to Decision 28 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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