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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 K190585
Device Name Biocode Gastrointestinal Pathogen Panel (GPP)
Applicant
Applied Biocode, Inc.
10020 Pioneer Blvd.
Suite 102
Santa Fe Springs,  CA  90067 0
Applicant Contact Robert Di Tullio
Correspondent
Applied Biocode, Inc.
10020 Pioneer Blvd.
Suite 102
Santa Fe Springs,  CA  90067 0
Correspondent Contact Robert Di Tullio
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
OOI  
Date Received03/06/2019
Decision Date 06/05/2019
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
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