K102638

Substantially Equivalent

DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS

Applicant: Diazyme Laboratories
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2010-09-14
Decision date: 2010-11-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Poway, CA, US

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