510(k) K231137
K231137 is an FDA 510(k) premarket notification submitted by Xenta Biomedical Science Co., Ltd. for the device "Xenta Drug Screen Cup, Xenta Drug Screen Dipcard". The FDA issued a decision of Substantially Equivalent on May 19, 2023. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Xenta Biomedical Science Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2023
- Date Received
- April 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type