DeviceClearance

DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX— 510(k) K073488

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K073488 for DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX, Substantially Equivalent on 2008-03-07. Applicant: Diazyme Laboratories.

Clearance details

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