Cleared Traditional

CYBOW READER, MODELS 300 & 720

K102188 · DFI Co., Ltd. · Chemistry
Aug 2011
Decision
371d
Days
Class 1
Risk

About This 510(k) Submission

K102188 is an FDA 510(k) clearance for the CYBOW READER, MODELS 300 & 720, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by DFI Co., Ltd. (Gangnam-Gu, Seoul, KR). The FDA issued a Cleared decision on August 9, 2011, 371 days after receiving the submission on August 3, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K102188 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2010
Decision Date August 09, 2011
Days to Decision 371 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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