Sickle-Check

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K820642 ↗

FDA Product Code

GHM

Device Class

Class II

Regulation

21 CFR Part 864.7825

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Postassium Buffer Sol. & Wash Solution

  Class II

  FDA 510(k) K802158 Active Cleared 10 Oct 1980

• Alfatest

  Class I

  FDA 510(k) K780542 Active Cleared 19 May 1978

• Bun Color Reagent & Bun Acid Used

  Class II

  FDA 510(k) K802160 Active Cleared 10 Oct 1980

• Reagents Used-Quan. Measure of Serum

  Class II

  FDA 510(k) K802154 Active Cleared 10 Oct 1980

• 8-Hydroxyquinoline, Cresolphthalein Com.

  Class II

  FDA 510(k) K802164 Active Cleared 10 Oct 1980

• Reagents Serum Sodium Using the Tech.

  Class II

  FDA 510(k) K802155 Active Cleared 10 Oct 1980

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