Compur* M1100 Hematrcrit System

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K831318 ↗

FDA Product Code

JPI

Device Class

Class II

Regulation

21 CFR Part 864.6400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Easytouch Hemoglobin Reagent

  Class II

  FDA 510(k) K832750 Active Cleared 26 Sep 1983

• Easytouch Bun Reagent Set

  Class II

  FDA 510(k) K832749 Active Cleared 14 Oct 1983

• Tia-Iga Reagent & Calibrator Sets

  Class II

  FDA 510(k) K831102 Active Cleared 27 Apr 1983

• Szamyl 6.5

  Class II

  FDA 510(k) K790474 Active Cleared 1 May 1979

• Worthington Triglycerides Reagent Set

  Class I

  FDA 510(k) K791962 Active Cleared 5 Nov 1979

• Serum T4 by Enzyme Immunoassay

  Class II

  FDA 510(k) K802573 Active Cleared 24 Nov 1980

See all devices from Worthington Diagnostic Systems →