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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Epithelial Ovarian Tumor Associated Antigen (He4)
510(k) Number K151378
Device Name Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Applicant Contact Diana Dickson
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Correspondent Contact Stacey Dolan
Regulation Number866.6010
Classification Product Code
OIU  
Subsequent Product Code
JIT  
Date Received05/22/2015
Decision Date 11/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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