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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K192485
Device Name BioCode Respiratory Pathogen Panel (RPP)
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 Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
NSU   OEM   OEP   OOU   OTG  
OZE   OZX   OZY   OZZ  
Date Received09/10/2019
Decision Date 12/23/2019
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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