DIAZYME SODIUM ENZYMATIC ASSAY— 510(k) K042189

Name: FDA 510(k) clearance K042189
Creator: U.S. Food and Drug Administration
Published: 2004-10-07

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K042189 for DIAZYME SODIUM ENZYMATIC ASSAY, Substantially Equivalent on 2004-10-07. Applicant: Diazyme Laboratories. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code MZU
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 2004-08-12
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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