Wondfo Propoxyphene Urine Test— 510(k) K152495
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K152495 for Wondfo Propoxyphene Urine Test, Substantially Equivalent on 2015-11-23. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code JXN
- Device class
- Class 2
- Regulation
- 21 CFR 862.3700
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.