Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
FDA 510(k) clearance K222955 · decided 2023-02-06
Clearance details
- K-number
- K222955
- Device name
- Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
- Applicant
- Xenta Biomedical Science Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-27
- Decision date
- 2023-02-06
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.