Device type
Hemoglobin A1c Test System
Product code PDJ · Class II · 21 CFR 862.1373 · Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Recent 510(k)s
Oct 2, 2026
K260468
H100Plus Hemoglobin Testing System
Shenzhen Lifotronic Technology Co., Ltd.
- PDJ
- Class II
Recent recalls
No recalls in the archive for PDJ.