Cleared Traditional

LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION

K103553 · Bionostics, Inc. · Chemistry
Feb 2011
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K103553 is an FDA 510(k) clearance for the LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE 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 February 10, 2011, 69 days after receiving the submission on December 3, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K103553 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2010
Decision Date February 10, 2011
Days to Decision 69 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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