Cleared Traditional

DROPPER A1C DIABETES CONTROL

K103744 · Quantimetrix Corp. · Chemistry
May 2011
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K103744 is an FDA 510(k) clearance for the DROPPER A1C DIABETES CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on May 12, 2011, 140 days after receiving the submission on December 23, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K103744 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2010
Decision Date May 12, 2011
Days to Decision 140 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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