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Cal-Chex, a Hematology Calibrator

by Streck Laboratories, Inc.

510(k) K840261

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 NumberK840261 Date21 Feb 1984ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2086-2025 FDA Class II initiated 4 Jun 2025

    Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

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  • Withdrawn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
KRZ
Device Class
Class II
Regulation
21 CFR Part 864.8165
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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