DeviceClearance

HE4 EIA, MODEL: 404-10 US— 510(k) K072939

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K072939 for HE4 EIA, MODEL: 404-10 US, Substantially Equivalent on 2008-06-09. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant
Fujirebio Diagnostics,Inc.
Product code
Code OIU
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Malvern, PA, US
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