510(k) K212856
K212856 is an FDA 510(k) premarket notification submitted by Huachenyang (Shenzhen) Technology Co. , Ltd. for the device "iClean Viral Transport System (VTM-RT kit)". The FDA issued a decision of Substantially Equivalent on Aug 18, 2022. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 2022
- Date Received
- Sep 8, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Culture Media, Non-Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type
- 510(k)