OmniTrans Transport System

FDA 510(k) K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd.

Substantially Equivalent

510(k) numberK240235

Submission

Device name
OmniTrans Transport System
Applicant
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Shenzhen, CN
Received
January 29, 2024
Decision date
August 19, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JSM – Culture Media, Non-Propagating Transport
Device class
Class I (low risk)
Regulation
21 CFR 866.2390
Specialty
Microbiology

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Questions and answers

When was OmniTrans Transport System cleared by the FDA?

OmniTrans Transport System (K240235) received a 510(k) decision of Substantially Equivalent on August 19, 2024, 203 days after the submission was received.

What is the product code of K240235?

The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.