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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 a medical device manufactured by Applied BioCode, Inc.. It received FDA 510(k) clearance on 2026-05-01 under approval 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. It is manufactured by Applied BioCode, Inc.. The 510(k) number is K254139.

When was BioCode® Respiratory Pathogen Panel (RPP) approved by the FDA?

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

What company makes BioCode® Respiratory Pathogen Panel (RPP)?

BioCode® Respiratory Pathogen Panel (RPP) is manufactured by Applied BioCode, Inc..

What is the FDA product code for BioCode® Respiratory Pathogen Panel (RPP)?

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

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.

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