DeviceClearance

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS— 510(k) K072523

Substantially Equivalent

General Atomics

FDA 510(k) clearance K072523 for DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS, Substantially Equivalent on 2008-01-22. Applicant: General Atomics.

Clearance details

Applicant
General Atomics
Product code
Code LBR
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Poway, CA, US
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