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 IDK180041
510k NumberK180041
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  90670
ContactRobert Di Tullio
CorrespondentRobert Di Tullio
Applied Biocode, Inc. 10020 Pioneer Blvd. Suite 102 Santa Fe Springs,  CA  90670
Product CodePCH  
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-05
Decision Date2018-09-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851034007011 K180041 000
00851034007004 K180041 000

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