# K964004: Glucometer Encore Blood Glucose Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Feb 10, 1997 after 126 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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. The FDA summary names its predicate without a number.
- (no number) GLUCOMETER ENCORE Blood Glucose Test Strips: named in the summary without a submission number
- (no number) ACCU-CHEK® ADVANTAGE™ H Blood Glucose System: named in the summary without a submission number

## Indications for use
GLUCOMETER ENCORE Blood Glucose Test Strips are over-the-counter home tests for glucose in blood. They are for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. GLUCOMETER ENCORE Blood Glucose Test Strips are for use with GLUCOMETER ENCORE® Blood Glucose Meters. GLUCOMETER ENCORE Blood Glucose Test Strips are for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes

Source page: https://510kreport.com/device/K964004
Methodology: https://510kreport.com/methodology