DIAZYME POTASSIUM ENZYMATIC ASSAY KIT— 510(k) K042191

Name: FDA 510(k) clearance K042191
Creator: U.S. Food and Drug Administration
Published: 2004-10-29

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K042191 for DIAZYME POTASSIUM ENZYMATIC ASSAY KIT, Substantially Equivalent on 2004-10-29. Applicant: Diazyme Laboratories. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code MZV
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2004-08-12
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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