The following data is part of a premarket notification filed by Wuxi Nest Biotechnology Co., Ltd. with the FDA for Disposable Sampler Viral Transport Media.
Device ID | K211256 |
510k Number | K211256 |
Device Name: | Disposable Sampler Viral Transport Media |
Classification | Culture Media, Non-propagating Transport |
Applicant | Wuxi Nest Biotechnology Co., Ltd. No.530 Xida Road, New District Wuxi, CN 214112 |
Contact | Cheng Zhiwei |
Correspondent | Randy Jiang Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-26 |
Decision Date | 2022-05-20 |