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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name procalcitonin assay
510(k) Number K172713
Device Name Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set
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 Number866.3215
Classification Product Code
PRI  
Subsequent Product Codes
NTM   PMT  
Date Received09/08/2017
Decision Date 12/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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