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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K163544
Device Name Lumipulse G Prolactin
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Applicant Contact STACEY DOLAN
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Correspondent Contact STACEY DOLAN
Regulation Number862.1150
Classification Product Code
JIT  
Date Received12/16/2016
Decision Date 01/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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