CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
FDA 510(k) clearance K180255 · decided 2018-02-28
Clearance details
- K-number
- K180255
- Device name
- CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- Applicant
- Hangzhou Clongene Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-01-30
- Decision date
- 2018-02-28
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- PTH
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.