DeviceClearance

ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)— 510(k) K071706

Substantially Equivalent

Clinical Data, Inc.

FDA 510(k) clearance K071706 for ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118), Substantially Equivalent on 2007-12-20. Applicant: Clinical Data, Inc..

Clearance details

Applicant
Clinical Data, Inc.
Product code
Code LBS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
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