SE-Check

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K940181 ↗

FDA Product Code

JPK

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Para 12 Plus

  Class II

  FDA 510(k) K901875 Active Cleared 30 May 1990

• Para 12 Plus Retics

  Class II

  CE/IVDR FDA 510(k) K000945 Active Cleared 18 Apr 2000

• Retic Chex Linearity

  Class II

  FDA 510(k) K000115 Active Cleared 27 Mar 2000

• Platelet-Chex-Human

  Class II

  FDA 510(k) K770020 Active Cleared 16 Feb 1977

• Cal-Chex Cd Plus

  Class II

  FDA 510(k) K020469 Active Cleared 4 Apr 2002

• Chem-Chex Stat

  Class I

  FDA 510(k) K961195 Active Cleared 15 May 1996

See all devices from Streck Laboratories, Inc. →

• What is the SE-Check used for in a hematology lab?

  The SE-Check is a quality control mixture designed specifically for hematology laboratories. It serves as a standardized reference sample to monitor and validate the performance of automated hematology analyzers. By providing a consistent, controlled environment, it helps ensure accuracy and reliability in blood cell counting and differential analysis, which is critical for diagnostic precision and patient care.

• Is the SE-Check sterile, and how should it be handled?

  The SE-Check is not sterile, but it is intended for use in controlled laboratory environments where contamination risks are minimized. Since it is a single-use liquid mixture, it should be handled according to standard laboratory quality control procedures. Always follow the storage conditions and expiration dates specified on the packaging to maintain its integrity and effectiveness.

• How is the SE-Check supplied, and is it reusable?

  The SE-Check is supplied as a liquid mixture in a single-use format, meaning each unit is intended for one-time use only. This design ensures consistency in quality control testing without carryover risks from reuse. Laboratories should adhere to single-use protocols to maintain accuracy and prevent cross-contamination between tests.

• What regulatory pathway does the SE-Check follow, and what does this mean for users?

  The SE-Check is regulated under the FDA’s Traditional 510(k) review pathway and has received FDA 510(k) clearance (K940181). This classification as a Class II medical device means it has undergone evaluation to ensure its safety and effectiveness for its intended use in hematology quality control. Users can rely on its compliance with FDA standards, though they should still follow manufacturer guidelines and local regulatory requirements for proper implementation.

• Are there different sizes or models of the SE-Check, and how do I identify the correct one?

  The SE-Check is available in multiple lot or batch numbers (e.g., 1950302, 3010939897, etc.), which may correspond to different production runs or formulations. While the core functionality remains consistent across these lots, each batch should be checked for expiration dates and storage instructions on the packaging. The device’s primary distinguishing feature is its role as a hematology quality control mixture, so no additional models exist beyond these lot-specific variations.