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Kodak Ektachem Clinical Chemistry Slide Alcohol (Alc)

by Eastman Kodak Company

510(k) K934273

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934273 Date21 Mar 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0295-2014 FDA Class II initiated 12 Jun 2013

    Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

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  • Withdrawn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
DMT
Device Class
Class II
Regulation
21 CFR Part 862.3040
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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