# K023032: Liquitrol, Liquid Human Glycosyla,Ted Hemoglobin (A1C) Control - Normal/Abnormal

- Pathway: 510(k) (Traditional)
- Applicant: Bioresource Technology, Inc.
- Decided: Oct 8, 2002 after 27 days
- Product code: GFS (Standards And Controls, Hemoglobin, Normal And Abnormal)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Liquid Human Glycosylated Hemoglobin (AIC) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (AlC) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.

Source page: https://510kreport.com/device/K023032
Methodology: https://510kreport.com/methodology