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FDA 510(k)

BioCode® Respiratory Pathogen Panel (RPP)

K-Number: K254139 · 2026-05-01

ApplicantApplied BioCode, Inc.
Decision Date2026-05-01
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioCode® Respiratory Pathogen Panel (RPP) 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 2026-05-01 under 510(k) number K254139. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioCode® Respiratory Pathogen Panel (RPP)?

BioCode® Respiratory Pathogen Panel (RPP) is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Applied BioCode, Inc.. The 510(k) number is K254139.

When did BioCode® Respiratory Pathogen Panel (RPP) receive FDA 510(k) clearance?

BioCode® Respiratory Pathogen Panel (RPP) received FDA 510(k) clearance on 2026-05-01, under 510(k) number K254139.

Who is the listed applicant for BioCode® Respiratory Pathogen Panel (RPP)?

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® Respiratory Pathogen Panel (RPP)?

The FDA product code for BioCode® Respiratory Pathogen Panel (RPP) is OCC.

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.

K242877BioCode Gastrointestinal Pathogen Panel (GPP)K192485BioCode Respiratory Pathogen Panel (RPP)K190585Biocode Gastrointestinal Pathogen Panel (GPP)K180041BioCode Gastrointestinal Pathogen Panel (GPP)

Related Devices (Code: OCC)

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.

K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackDiasorin Molecular, LLC

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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