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Gds Enzymatic B-Hydroxybutyrate Reagent Modified

by Gds Diagnostics

510(k) K910108

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910108 Date4 Mar 1991ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2201-2021 FDA Class III initiated 12 Jul 2021
    • Terminated Z-2199-2021 FDA Class III initiated 12 Jul 2021
    • Terminated Z-2203-2021 FDA Class III initiated 12 Jul 2021
    • Terminated Z-2202-2021 FDA Class III initiated 12 Jul 2021
    • Terminated Z-2200-2021 FDA Class III initiated 12 Jul 2021

    Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JIN
Device Class
Class I
Regulation
21 CFR Part 862.1435
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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