Cleared Traditional

POCKETCHEM UA AUTION STICKS 10TA

K022386 · Arkray, Inc. · Chemistry
Sep 2002
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K022386 is an FDA 510(k) clearance for the POCKETCHEM UA AUTION STICKS 10TA, a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIL), submitted by Arkray, Inc. (Beverly, US). The FDA issued a Cleared decision on September 17, 2002, 57 days after receiving the submission on July 22, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K022386 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2002
Decision Date September 17, 2002
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340

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