Avantik VTM

FDA 510(k) K233449 · Hanchang Medic Co., Ltd. (Han Chang Medic)

Substantially Equivalent

510(k) numberK233449

Submission

Device name
Avantik VTM
Applicant
Hanchang Medic Co., Ltd. (Han Chang Medic)
Asan-Si, KR
Received
October 20, 2023
Decision date
July 15, 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

Other 510(k)s with product code JSM

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K242576AllTest Viral Transport MediumJSM · Traditional Hangzhou AllTest Biotech Co., Ltd.04/04/2025SE
K232565UriSponge™JSM · Traditional Copan Italia Spa10/11/2024SE
K220908Ensol EnTM Specimen Collection and Transport SystemJSM · Traditional Ensol Biosciences, Inc.08/29/2024SE
K240235OmniTrans Transport SystemJSM · Traditional Shenzhen Dakewe Bio-Engineering Co., Ltd.08/19/2024SE
K233534Viral Transport MediumJSM · Traditional Hardy Diagnostics08/02/2024SE
K232454Viral Transport Media (VTM)JSM · Traditional Alb Luz05/03/2024SE
K232357Copan Universal Transport Medium (UTM-RT) SystemJSM · Traditional Copan Italia Spa04/25/2024SE
K202531Azer Scientific Universal Transport MediumJSM · Traditional Azer Scientific, Inc.04/11/2024SE

Questions and answers

When was Avantik VTM cleared by the FDA?

Avantik VTM (K233449) received a 510(k) decision of Substantially Equivalent on July 15, 2024, 269 days after the submission was received.

What is the product code of K233449?

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