# K851636: Diamat Glycoslated Hemoglobin Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jul 30, 1985 after 102 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983172: Accu-Base Hemoglobin A1C Sample Collection Kit (1998), 2 descendants of its own
- K993787: Appraise-Cardio Sample Collection Kit (2000), 1 descendant of its own
- K021698: MY Allergy Test (2002), 0 descendants of its own
- K992085: Abbott Imx Glycated Hemoglobin II (2000), 0 descendants of its own
- K991483: Abbott Architect Glycated Hemoglobin (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K851636
Methodology: https://510kreport.com/methodology