510(k) K222613
K222613 is an FDA 510(k) premarket notification submitted by Arx Sciences, Inc. for the device "ARX Liquid Amies Collection & Transport System". The FDA issued a decision of Substantially Equivalent on March 27, 2024. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Arx Sciences, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2024
- Date Received
- August 30, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type