ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS— 510(k) K050024
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K050024 for ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS, Substantially Equivalent on 2005-11-17. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yardley, PA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.