BioCode Respiratory Pathogen Panel (RPP)
K-Number: K192485 · 2019-12-23
ApplicantApplied BioCode, Inc.
Decision Date2019-12-23
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 2019-12-23 under approval number K192485. 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 2019-12-23. It is manufactured by Applied BioCode, Inc.. The 510(k) number is K192485.
When was BioCode Respiratory Pathogen Panel (RPP) approved by the FDA?
BioCode Respiratory Pathogen Panel (RPP) received FDA 510(k) clearance on 2019-12-23, under approval number K192485.
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.
Other Devices by Applied BioCode, Inc.
Related Devices (Code: OCC)
K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc.
K152579FilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLC
K161814Solana Influenza A+B AssayQuidel Corporation
K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc.
K161220ARIES® Flu A/B & RSV AssayLuminex Corporation
K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.
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.