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Hemoccult Ict

by Beckman Coulter, Inc.

510(k) K080812

Hemoccult Ict is a Class II device made by Beckman Coulter, Inc., cleared under FDA 510(k) K080812 on 25 Jun 2008, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080812 Date25 Jun 2008ClearedStatusActive

Official records

Recalls

2 recalls · FDA

    • Terminated Z-1997-2013 FDA Class II initiated 17 Jul 2013

    Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative.

    • Terminated Z-2197-2013 FDA Class II initiated 16 Jul 2013

    The products may have been stored at temperatures outside their required storage conditions.

Timeline

3 dated events

  1. Cleared FDA 510(k) K080812
  2. Recall initiated FDA recalls Z-2197-2013
  3. Recall initiated FDA recalls Z-1997-2013

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  • Withdrawn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
KHE
Device class
Class II
Regulation
21 CFR Part 864.6550
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code KHE (Reagent, Occult Blood).

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