Dart Amylase-D.S. Reagent System

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K862370 ↗

FDA Product Code

CIJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Coulter Retic-C Cell Control

  Class II

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• Coulter Uric Acid Reagent

  Class I

  FDA 510(k) K897161 Active Cleared 1 Mar 1990

• Coulter Direct Billrubin Reagent

  Class II

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• Coulter Total Protein Reagent

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• Chemistry, Coulter

  Class I

  FDA 510(k) K770679 Active Cleared 3 May 1977

See all devices from Coulter Electronics, Inc. →