Cleared Traditional

G4, MODEL IGM-0004

K051651 · U. S. Diagnostics, Inc. · Chemistry
Apr 2006
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K051651 is an FDA 510(k) clearance for the G4, MODEL IGM-0004, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by U. S. Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on April 14, 2006, 297 days after receiving the submission on June 21, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K051651 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2005
Decision Date April 14, 2006
Days to Decision 297 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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