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510(k) K192524

Lumipulse G CA15-3 by Fujirebio Diagnostics,Inc. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2020
Date Received
September 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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