Salicylate-Sl Assay

• • Terminated Z-0361-2007 FDA Unclassified (pre-2012) ·initiated 5 Dec 2006

  Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories

510(k) Number

K042329 ↗

FDA Product Code

DKJ

FDA applicant

Diagnostic Chemicals , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.3830

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Alkaline Phosphatase-Sl Assay Catalogue Number 309-10, 309-30

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• Hdl/Ldl-Advance Calibrator, Cat. No. Se-278

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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. →