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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K190702
Device Name Lumipulse G whole PTH
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 Number862.1545
Classification Product Code
CEW  
Date Received03/18/2019
Decision Date 08/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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