Cleared Traditional

MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL

K103387 · ACON Laboratories, Inc. · Chemistry
Feb 2011
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K103387 is an FDA 510(k) clearance for the MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on February 2, 2011, 76 days after receiving the submission on November 18, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K103387 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2010
Decision Date February 02, 2011
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJW — Urinalysis Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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