FDA 510(k)

Idylla Respiratory (IFV-RSV) Panel

K-Number: K163628 · 2017-08-30

Decision Date2017-08-30

Product CodeOCC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Idylla Respiratory (IFV-RSV) Panel is a medical device manufactured by Janssen Pharmaceutica NV. It received FDA 510(k) clearance on 2017-08-30 under approval 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. It is manufactured by Janssen Pharmaceutica NV. The 510(k) number is K163628.

When was Idylla Respiratory (IFV-RSV) Panel approved by the FDA?

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

What company makes Idylla Respiratory (IFV-RSV) Panel?

Idylla Respiratory (IFV-RSV) Panel is manufactured by Janssen Pharmaceutica NV.

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

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

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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.