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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, thyroid-stimulating hormone
510(k) Number K171103
Device Name Lumipulse G TSH-III Immunoreaction Cartridges
Applicant
Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
malvern,  PA  19355
Applicant Contact stacey dolan
Correspondent
Fujirebio Diagnostics, Inc.
201 Great Valley Parkway
malvern,  PA  19355
Correspondent Contact stacey dolan
Regulation Number862.1690
Classification Product Code
JLW  
Date Received04/13/2017
Decision Date 07/28/2017
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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