K070734

Substantially Equivalent

MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

Applicant: Diazyme Laboratories
Product code: LCP
Advisory panel: Hematology
Date received: 2007-03-16
Decision date: 2007-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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