510(k) K230035
K230035 is an FDA 510(k) premarket notification submitted by Shenzhen Dakewe Bio-Engineering Co., Ltd. for the device "BioSci Disposable Virus Sampling Tubes". The FDA issued a decision of Substantially Equivalent on April 5, 2023. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Shenzhen Dakewe Bio-Engineering Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2023
- Date Received
- January 5, 2023
- 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