CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup— 510(k) K180255
Substantially EquivalentHangzhou Clongene Biotech Co., Ltd.
FDA 510(k) clearance K180255 for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup, Substantially Equivalent on 2018-02-28. Applicant: Hangzhou Clongene Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Clongene Biotech Co., Ltd.
- Product code
- Code PTH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.