Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
FDA 510(k) clearance K250803 · decided 2025-04-15
Clearance details
- K-number
- K250803
- Device name
- Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
- Applicant
- Anhui Deepblue Medical Technological Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-17
- Decision date
- 2025-04-15
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- NGL
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hefei, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.