WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST— 510(k) K113624
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K113624 for WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST, Substantially Equivalent on 2012-03-12. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.