Cleared Special

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528

K062434 · Agamatrix · Chemistry
Nov 2006
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K062434 is an FDA 510(k) clearance for the ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528, 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 November 13, 2006, 84 days after receiving the submission on August 21, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K062434 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2006
Decision Date November 13, 2006
Days to Decision 84 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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