510(k) K212743
K212743 is an FDA 510(k) premarket notification submitted by Medschenker, Inc. for the device "MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System". The FDA issued a decision of Substantially Equivalent on May 3, 2023. 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
- May 3, 2023
- Date Received
- August 30, 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