Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2017-10-23 under approval 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. It is manufactured by Hologic, Inc.. The 510(k) number is K172282.

When was Panther Fusion Paraflu Assay approved by the FDA?

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

What company makes Panther Fusion Paraflu Assay?

Panther Fusion Paraflu Assay is manufactured by Hologic, Inc..

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

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

Other Devices by Hologic, Inc.

K153486Affirm Prone Biopsy System K172629Panther Fusion AdV/hMPV/RV Assay K163623Quantra K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices K162673Aptima Herpes Simplex Viruses 1 & 2 Assay

View all 54 devices →

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.

↑