WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)— 510(k) K122961
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K122961 for WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500), Substantially Equivalent on 2012-12-21. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- 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.