510(k) K211256

Disposable Sampler Viral Transport Media by Wuxi Nest Biotechnology Co., Ltd. — Product Code JSM

K211256 is an FDA 510(k) premarket notification submitted by Wuxi Nest Biotechnology Co., Ltd. for the device "Disposable Sampler Viral Transport Media". The FDA issued a decision of Substantially Equivalent on May 20, 2022. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Wuxi Nest Biotechnology Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2022
Date Received
April 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type