DeviceClearance

DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET— 510(k) K112120

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K112120 for DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET, Substantially Equivalent on 2013-01-24. Applicant: Diazyme Laboratories.

Clearance details

Applicant
Diazyme Laboratories
Product code
Code GHH
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Poway, CA, US
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