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FDA 510(k)

Panther Fusion Paraflu Assay

K-Number: K172282 · 2017-10-23

ApplicantHologic, Inc.
Decision Date2017-10-23
Product CodeOOU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Panther Fusion Paraflu Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K172282. The device is classified under product code OOU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther Fusion Paraflu Assay?

Panther Fusion Paraflu Assay is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Hologic, Inc.. The 510(k) number is K172282.

When did Panther Fusion Paraflu Assay receive FDA 510(k) clearance?

Panther Fusion Paraflu Assay received FDA 510(k) clearance on 2017-10-23, under 510(k) number K172282.

Who is the listed applicant for Panther Fusion Paraflu Assay?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Panther Fusion Paraflu Assay?

The FDA product code for Panther Fusion Paraflu Assay is OOU.

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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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