Glucometer Dex Diabetes Care System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K963500 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Clinitek Hcg Test Strips

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• Glucometer Elite Xl Blood Glucose Meter

  Class II

  FDA 510(k) K990649 Active Cleared 9 Jul 1999

See all devices from Bayer Corp. →