Cleared Traditional

K240235 - OmniTrans Transport System
(FDA 510(k) Clearance)

K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Microbiology

Aug 2024

Decision

203d

Days

Class 1

Risk

K240235 is an FDA 510(k) clearance for the OmniTrans Transport System, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Shenzhen Dakewe Bio-Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 19, 2024, 203 days after receiving the submission on January 29, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number	K240235 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2024
Decision Date	August 19, 2024
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF