Dade Colorimetric Amylase

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K813529 ↗

FDA Product Code

CIJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary function of the Dade Colorimetric Amylase?

  This device is designed for use in clinical chemistry settings to facilitate the measurement of amylase activity within laboratory samples.

• What is the regulatory classification of this device?

  The Dade Colorimetric Amylase is classified as a Class II medical device under regulation number 862.1070 and has received FDA 510(k) clearance.

• What type of amylase measurement does this device perform?

  This device is specifically designed as a saccharogenic amylase device, which is the method used to quantify amylase activity for clinical chemistry analysis.