Trueresult Blood Glucose System E4H01-81

by Home Diagnostics, Inc.

510(k) K080641

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

510(k) K080641↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080641	Date19 Aug 2008Cleared	StatusActive

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2880-2016 FDA Class II initiated 28 Jun 2016
Product gives incorrect low blood glucose levels.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K080641
FDA Product Code: NBW

Device Class: Class II
Regulation: 21 CFR Part 862.1345
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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