Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators— 510(k) K151378

Clearance details

Applicant

Fujirebio Diagnostics,Inc.

Product code

Code OIU

Device class

Class 2

Regulation

21 CFR 866.6010

Advisory panel

Immunology

Date received

2015-05-22

Decision date

2015-11-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Malvern, PA, US

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