# K141750: Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Jul 24, 2014 after 24 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K950727 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121366: Hemocue HBA1C 501, Infopia Co, Ltd. (2012) Summary page 1.

Source page: https://510kreport.com/device/K141750
Methodology: https://510kreport.com/methodology