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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K170883
Device Name FilmArray NGDS Warrior Panel
Applicant
BioFire Defense, LLC
79 West 4500 South, Suite 14
Salt Lake City,  UT  84107
Applicant Contact Cynthia Phillips
Correspondent
BioFire Defense, LLC
79 West 4500 South, Suite 14
Salt Lake City,  UT  84107
Correspondent Contact Cynthia Phillips
Classification Product Code
PRD
Subsequent Product Code
NSU  
Date Received03/24/2017
Decision Date 06/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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