BIOEASY Multi-Drug Test Cup
FDA 510(k) clearance K193480 · decided 2020-01-31
Clearance details
- K-number
- K193480
- Device name
- BIOEASY Multi-Drug Test Cup
- Applicant
- Shenzhen Bioeasy Biotechnology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-16
- Decision date
- 2020-01-31
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- NGL
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.