Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
FDA 510(k) clearance K242428 · decided 2025-02-06
Clearance details
- K-number
- K242428
- Device name
- Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
- Applicant
- Guangzhou Decheng Biotechnology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-15
- Decision date
- 2025-02-06
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- NGL
- 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.