SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
FDA 510(k) clearance K182654 · decided 2018-11-19
Clearance details
- K-number
- K182654
- Device name
- SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-25
- Decision date
- 2018-11-19
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- NGG
- Device class
- 2
- Regulation number
- 862.3610
- 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.