510(k) K071971— DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL

Substantially Equivalent

Diazyme Laboratories

Clearance details

Applicant: Diazyme Laboratories
Product code: Code LPS
Advisory panel: Clinical Chemistry
Date received: 2007-07-17
Decision date: 2007-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Poway, CA, US

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