510(k) K210440
K210440 is an FDA 510(k) premarket notification submitted by Wuxi Nest Biotechnology Co., Ltd. for the device "Disposable Sampler Inactivated Transport Media, Nest ITM". The FDA issued a decision of Substantially Equivalent on September 20, 2021. The device falls under product code QBD (Microbial Nucleic Acid Storage And Stabilization Device), a Class II device regulated under 21 CFR 866.2950. Wuxi Nest Biotechnology Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2021
- Date Received
- February 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microbial Nucleic Acid Storage And Stabilization Device
- Device Class
- Class II
- Regulation Number
- 866.2950
- Review Panel
- MI
- Submission Type
Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.