Atlas FDA

BioCode® Respiratory Pathogen Panel (RPP)

FDA 510(k) clearance K254139 · decided 2026-05-01

Clearance details

K-number
K254139
Device name
BioCode® Respiratory Pathogen Panel (RPP)
Applicant
Applied BioCode, Inc.
Decision
Substantially Equivalent
Date received
2025-12-22
Decision date
2026-05-01
Days to decision
130 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Santa Fe Springs, CA, US
Third-party review
No
Expedited review
No

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BioCode Respiratory Pathogen Panel (RPP) (K192485)Applied BioCode, Inc.2019-12-23
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167)Luminex Molecular Diagnostics, Inc.2019-12-11
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729)Roche Molecular Systems, Inc.2019-07-24
ID NOW Influenza A & B 2 (K191534)Abbott Diagnostics Scarborough, Inc.2019-07-11
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Recalls involving this device

No recalls on record reference this clearance.