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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 the device name listed in this FDA 510(k) record. The listed applicant is Applied BioCode, Inc.. It received FDA 510(k) clearance on 2019-06-05 under 510(k) 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. The listed applicant is Applied BioCode, Inc.. The 510(k) number is K190585.

When did Biocode Gastrointestinal Pathogen Panel (GPP) receive FDA 510(k) clearance?

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

Who is the listed applicant for Biocode Gastrointestinal Pathogen Panel (GPP)?

The FDA 510(k) record lists Applied BioCode, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Applied BioCode, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: PCH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K251868Panther Fusion GI Bacterial AssayHologic

Official Source

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

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