Cleared Traditional

GLUCOSE CONTROL SOLUTION FOR BD LATITUDE

K021697 · Bionostics, Inc. · Chemistry
Jul 2002
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K021697 is an FDA 510(k) clearance for the GLUCOSE CONTROL SOLUTION FOR BD LATITUDE, 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 July 12, 2002, 51 days after receiving the submission on May 22, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K021697 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2002
Decision Date July 12, 2002
Days to Decision 51 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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