510(k) DEN250004
- Device
- QIKCAP System
- Applicant
- Hai Solutions
- 510(k) number
- DEN250004
- Product code
- SGX
- Decision
- Unknown (DENG)
- Decision date
- 2025-12-23
- Date received
- 2025-01-30
- Regulation
- 880.6512
- Classification name
- Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Brittany Batts
- Address
- 1902 Wright Pl. Suite 200 Carlsbad CA US 92008 92008
FDA Registration Numbers
- 3043650423
Source Documents
510(k) summary PDF not indicated by FDA