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FDA 510(k)

Idylla Respiratory (IFV-RSV) Panel

K-Number: K163628 · 2017-08-30

ApplicantJanssen Pharmaceutica NV
Decision Date2017-08-30
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Idylla Respiratory (IFV-RSV) Panel is the device name listed in this FDA 510(k) record. The listed applicant is Janssen Pharmaceutica NV. It received FDA 510(k) clearance on 2017-08-30 under 510(k) number K163628. 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 Idylla Respiratory (IFV-RSV) Panel?

Idylla Respiratory (IFV-RSV) Panel is a medical device that received FDA 510(k) clearance on 2017-08-30. The listed applicant is Janssen Pharmaceutica NV. The 510(k) number is K163628.

When did Idylla Respiratory (IFV-RSV) Panel receive FDA 510(k) clearance?

Idylla Respiratory (IFV-RSV) Panel received FDA 510(k) clearance on 2017-08-30, under 510(k) number K163628.

Who is the listed applicant for Idylla Respiratory (IFV-RSV) Panel?

The FDA 510(k) record lists Janssen Pharmaceutica NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Idylla Respiratory (IFV-RSV) Panel?

The FDA product code for Idylla Respiratory (IFV-RSV) Panel is OCC.

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.

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.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.

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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