# K911141: Hemocue (R) B-Glucose Microcuvette/Photometer

- Pathway: 510(k) (Traditional)
- Applicant: Hemocue, Inc.
- Decided: May 8, 1991 after 55 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 24, 2025 · Class II · Z-1827-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the

Source page: https://510kreport.com/device/K911141
Methodology: https://510kreport.com/methodology