510(k) K231843
K231843 is an FDA 510(k) premarket notification submitted by Arx Sciences, Inc. for the device "ARX Viral Transport Media Collection and Transport System". The FDA issued a decision of Substantially Equivalent on March 19, 2024. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Arx Sciences, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2024
- Date Received
- June 22, 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