The following data is part of a premarket notification filed by Bioteke Corporation (wuxi) Co., Ltd with the FDA for Bioteke Sterile Disposable Virus Sampling Kit.
| Device ID | K211707 |
| 510k Number | K211707 |
| Device Name: | BioTeke Sterile Disposable Virus Sampling Kit |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | BioTeke Corporation (WuXi) Co., Ltd 4th Floor, D5, No. 1719, Huishan Avenue Wuxi City, CN 21474 |
| Contact | Zhitu Zhou |
| Correspondent | Kenneth Kleinhenz QSR Consulting 10807 Dakota Ranch Rd. Santee, CA 92071 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2022-05-04 |