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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Influenza A And Influenza B Multiplex Nucleic Acid Assay
510(k) Number K182513
Device Name FluChip-8G Influenza A+B Assay
Applicant
InDevR, Inc.
2100 Central Avenue, Suite 106
Boulder,  CO  80301
Applicant Contact Erica Dawson
Correspondent
InDevR, Inc.
2100 Central Avenue, Suite 106
Boulder,  CO  80301
Correspondent Contact Erica Dawson
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Codes
NSU   OEP   OQW  
Date Received09/12/2018
Decision Date 04/22/2019
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
Predetermined Change
Control Plan Authorized		 No
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