Coulter Stks With Reticulocyte Analysis Capability

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K932030 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coulter Albumin Reagent

  Class II

  FDA 510(k) K901268 Active Cleared 30 May 1990

• Coulter Ck (Creatine Kinase) Reagent

  Class II

  FDA 510(k) K901267 Active Cleared 23 May 1990

• Coulter Hdl - Cholesterol Reagent

  Class I

  FDA 510(k) K902174 Active Cleared 31 Jul 1990

• Coulter Total Bilirubin Reagent

  Class II

  FDA 510(k) K901266 Active Cleared 25 Apr 1990

• Coulter Linearity Control

  Class II

  FDA 510(k) K955334 Active Cleared 8 Feb 1996

• Immuno-Trol Control Cells

  Class II

  FDA 510(k) K984216 Active Cleared 16 Mar 1999

See all devices from Coulter Corp. →

• What is the COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY used for?

  It is designed to perform cell counting and differential analysis, including reticulocyte analysis capability, as a Counter, Differential Cell in hematology testing environments.

• How was the COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY cleared for market?

  The device received traditional 510(k) clearance (K932030) from the FDA on August 23, 1993, and is classified as a Class II medical device based on substantial equivalence.

• Who manufactures the COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY and where is it located?

  The device is manufactured by Coulter Corp., with its address listed as 11800 SW 147th Ave., Miami, FL 33196, United States.