Hichem Isekci Solution Kit 70010

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

510(k) Number

K953862 ↗

FDA Product Code

CGZ

Device Class

Class II

Regulation

21 CFR Part 862.1170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hi Chem Enzyme Linearity Standards (Prod. 88235)

  Class I

  FDA 510(k) K902321 Active Cleared 28 Jun 1990

• Uric Acid Reagent (Product #88219)

  Class I

  FDA 510(k) K883404 Active Cleared 13 Sep 1988

• Triglycerides Reagent (Product #88218)

  Class I

  FDA 510(k) K883405 Active Cleared 13 Sep 1988

• Hichem Ldh/L Reagent Kit

  Class II

  FDA 510(k) K946022 Active Cleared 23 Feb 1995

• Hi Chem Triglycerides Calibrator E (88185)

  Class II

  FDA 510(k) K895585 Active Cleared 13 Nov 1989

• Hichem Calcium Reagent Kit

  Class II

  FDA 510(k) K981794 Active Cleared 29 Jul 1998

See all devices from Hichem Diagnostics →