# K904082: Cholestech Lipid Monitoring System, Glucose Test

- Pathway: 510(k) (Traditional)
- Applicant: Cholestech Corp.
- Decided: Dec 26, 1990 after 112 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K080123: Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201 (2008), 0 descendants of its own

## Recalls of this device
- Feb 18, 2011 · Not classified · Z-2402-2011: The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 

Source page: https://510kreport.com/device/K904082
Methodology: https://510kreport.com/methodology