HOMOCYSTEINE MICROTITER PLATE ASSAY— 510(k) K032012

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K032012 for HOMOCYSTEINE MICROTITER PLATE ASSAY, Substantially Equivalent on 2003-09-03. Applicant: Diazyme Laboratories.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code LPS
Advisory panel: Clinical Chemistry
Date received: 2003-06-30
Decision date: 2003-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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