510(k) K231843

ARX Viral Transport Media Collection and Transport System by Arx Sciences, Inc. — Product Code JSM

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