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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal pathogen panel multiplex nucleic acid-based assay system
510(k) Number K180041
Device Name BioCode Gastrointestinal Pathogen Panel (GPP)
Applicant
Applied Biocode, Inc.
10020 Pioneer Blvd.
Suite 102
Santa Fe Springs,  CA  90670
Applicant Contact Robert Di Tullio
Correspondent
Applied Biocode, Inc.
10020 Pioneer Blvd.
Suite 102
Santa Fe Springs,  CA  90670
Correspondent Contact Robert Di Tullio
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
OOI  
Date Received01/05/2018
Decision Date 09/28/2018
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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