Cleared Traditional

URISCAN OPTIMA

K141874 · Yd Diagnostics Corp. · Chemistry
May 2015
Decision
321d
Days
Class 1
Risk

About This 510(k) Submission

K141874 is an FDA 510(k) clearance for the URISCAN OPTIMA, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Yd Diagnostics Corp. (Gangnam-Gu, KR). The FDA issued a Cleared decision on May 28, 2015, 321 days after receiving the submission on July 11, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K141874 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2014
Decision Date May 28, 2015
Days to Decision 321 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

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