Cleared Traditional

Disposable Urine Collection Tube

K220739 · Zhejiang Gongdong Medical Technology Co., Ltd. · Microbiology
Nov 2022
Decision
248d
Days
Class 1
Risk

About This 510(k) Submission

K220739 is an FDA 510(k) clearance for the Disposable Urine Collection Tube, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Zhejiang Gongdong Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on November 17, 2022, 248 days after receiving the submission on March 14, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K220739 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2022
Decision Date November 17, 2022
Days to Decision 248 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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