Ammonia-L3K Assay, Catalogue Number 233-10

• • Terminated Z-1078-2017 FDA Class II ·initiated 29 Nov 2016

  Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

510(k) Number

K033921 ↗

FDA Product Code

JIF

FDA applicant

Diagnostic Chemicals , Ltd.

Device Class

Class I

Regulation

21 CFR Part 862.1065

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Urea-L3K Assay, Catalogue Number 283-17/10/30/50

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• Y-Glutamyltransferase-Sl Assay, Cataloge Number 324-10, 324-30

  Class I

  FDA 510(k) K974000 Active Cleared 4 Nov 1997

See all devices from Diagnostic Chemicals, Ltd. →