# K032076: Senova (R) Blood Glucose Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Chdiagnostics, LLC
- Decided: Sep 30, 2003 after 85 days
- Product code: LFR (Glucose Dehydrogenase, 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
- Mar 14, 2005 · Not classified · Z-1546-05: A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.

Source page: https://510kreport.com/device/K032076
Methodology: https://510kreport.com/methodology