Cleared Traditional

LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION

K022769 · Bionostics, Inc. · Chemistry
Nov 2002
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K022769 is an FDA 510(k) clearance for the LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION, 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 November 13, 2002, 84 days after receiving the submission on August 21, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K022769 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2002
Decision Date November 13, 2002
Days to Decision 84 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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