510(k) K233449
K233449 is an FDA 510(k) premarket notification submitted by Hanchang Medic Co., Ltd. (Han Chang Medic) for the device "Avantik VTM". The FDA issued a decision of Substantially Equivalent on July 15, 2024. 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
- July 15, 2024
- Date Received
- October 20, 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