Cleared Traditional

GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE

K013147 · Bionostics, Inc. · Chemistry
Oct 2001
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K013147 is an FDA 510(k) clearance for the GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on October 24, 2001, 34 days after receiving the submission on September 20, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K013147 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2001
Decision Date October 24, 2001
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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