510(k) clearance
H100Plus Hemoglobin Testing System
- 510(k) number
- K260468
- Applicant
- Shenzhen Lifotronic Technology Co., Ltd.
- Decision date
- Oct 2, 2026
- Date received
- Feb 12, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PDJ
- Device type
- Hemoglobin A1c Test System
- Device class
- Class II
- Regulation
- 21 CFR 862.1373
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN