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Kodatrol I and II Control and Diluent Set

by Eastman Kodak Company

510(k) K904768

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK904768 Date9 Nov 1990ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0471-2021 FDA Class III initiated 16 Oct 2020

    Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

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  • Withdrawn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
JJY
Device Class
Class I
Regulation
21 CFR Part 862.1660
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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