Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Biocode Gastrointestinal Pathogen Panel (GPP)

K-Number: K190585 · 2019-06-05

ApplicantApplied BioCode, Inc.
Decision Date2019-06-05
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Biocode Gastrointestinal Pathogen Panel (GPP) is a medical device manufactured by Applied BioCode, Inc.. It received FDA 510(k) clearance on 2019-06-05 under approval number K190585. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biocode Gastrointestinal Pathogen Panel (GPP)?

Biocode Gastrointestinal Pathogen Panel (GPP) is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Applied BioCode, Inc.. The 510(k) number is K190585.

When was Biocode Gastrointestinal Pathogen Panel (GPP) approved by the FDA?

Biocode Gastrointestinal Pathogen Panel (GPP) received FDA 510(k) clearance on 2019-06-05, under approval number K190585.

What company makes Biocode Gastrointestinal Pathogen Panel (GPP)?

Biocode Gastrointestinal Pathogen Panel (GPP) is manufactured by Applied BioCode, Inc..

What is the FDA product code for Biocode Gastrointestinal Pathogen Panel (GPP)?

The FDA product code for Biocode Gastrointestinal Pathogen Panel (GPP) is PCH.

Related Clinical Trials

NCT06681012 Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome RECRUITING

Other Devices by Applied BioCode, Inc.

K180041BioCode Gastrointestinal Pathogen Panel (GPP) K192485BioCode Respiratory Pathogen Panel (RPP) K242877BioCode Gastrointestinal Pathogen Panel (GPP) K254139BioCode® Respiratory Pathogen Panel (RPP)

Related Devices (Code: PCH)

K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC K152955Great Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc. K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. K181427BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson and Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑