DIAZYME SODIUM ENZYMATIC ASSAY— 510(k) K042189

Substantially Equivalent

Diazyme Laboratories

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

Clearance details

Applicant: Diazyme Laboratories
Product code: Code MZU
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

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