Quik-Sep Quantitive Hemoglobin S Controls

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K942222 ↗

FDA Product Code

JCM

Device Class

Class II

Regulation

21 CFR Part 864.7415

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hdl-Cholesterol Control Serum

  Class I

  FDA 510(k) K802997 Active Cleared 22 Dec 1980

• Resolve-Hb

  Class II

  FDA 510(k) K840011 Active Cleared 4 Feb 1984

• Sickle Hb Assay

  Class II

  FDA 510(k) K841170 Active Cleared 4 Apr 1984

• Hemocard(Tm) Control

  Class II

  FDA 510(k) K924173 Active Cleared 1 Dec 1992

• Isolab's T4 Test Kit

  Class II

  FDA 510(k) K951014 Active Cleared 18 Oct 1996

• Scalpel

  Class I

  FDA 510(k) K780998 Active Cleared 27 Jul 1978

See all devices from Isolab, Inc. →