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Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle

by Iris International, Inc.

510(k) K093861

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

Recall on shared 510(k) K093861; other models may be affected

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 · Special NumberK093861 Date5 Feb 2010ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1597-2023 FDA Class II initiated 5 Apr 2023 on shared 510(k) K093861
    • Ongoing Z-1599-2023 FDA Class II initiated 5 Apr 2023 on shared 510(k) K093861
    • Ongoing Z-1598-2023 FDA Class II initiated 5 Apr 2023 on shared 510(k) K093861

    Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

    • Ongoing Z-1596-2023 FDA Class II initiated 5 Apr 2023 on shared 510(k) K093861

    Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
LKM
Device Class
Class II
Regulation
21 CFR Part 864.5200
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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