Biocode Gastrointestinal Pathogen Panel (GPP)

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

Applied Biocode, Inc.

The following data is part of a premarket notification filed by Applied Biocode, Inc. with the FDA for Biocode Gastrointestinal Pathogen Panel (gpp).

Pre-market Notification Details

Device IDK190585
510k NumberK190585
Device Name:Biocode Gastrointestinal Pathogen Panel (GPP)
ClassificationGastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Applicant Applied Biocode, Inc. 10020 Pioneer Blvd. Suite 102 Santa Fe Springs,  CA  90067 0
ContactRobert Di Tullio
CorrespondentRobert Di Tullio
Applied Biocode, Inc. 10020 Pioneer Blvd. Suite 102 Santa Fe Springs,  CA  90067 0
Product CodePCH  
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-06
Decision Date2019-06-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.