DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B— 510(k) K082763

Name: FDA 510(k) clearance K082763
Creator: U.S. Food and Drug Administration
Published: 2008-11-12

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K082763 for DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B, Substantially Equivalent on 2008-11-12. 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: 2008-09-22
Decision date: 2008-11-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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