510(k) K201674
K201674 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Cultura Collection and Transport System". The FDA issued a decision of Substantially Equivalent on Mar 3, 2021. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 2021
- Date Received
- Jun 19, 2020
- 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
- 510(k)