Cleared Traditional

ACON URINALYSIS REAGENT STRIPS

K061559 · Acon Laboratories Co. · Chemistry
Aug 2006
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K061559 is an FDA 510(k) clearance for the ACON URINALYSIS REAGENT STRIPS, a Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (Class I — General Controls, product code CDM), submitted by Acon Laboratories Co. (San Antonio, US). The FDA issued a Cleared decision on August 11, 2006, 67 days after receiving the submission on June 5, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1785.

Submission Details

510(k) Number K061559 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2006
Decision Date August 11, 2006
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDM — Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1785

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