FDA 510(k)

Panther Fusion GBS Assay

K-Number: K181156 · 2018-07-27

Decision Date2018-07-27

Product CodeNJR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Panther Fusion GBS Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diagenode. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K181156. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panther Fusion GBS Assay?

Panther Fusion GBS Assay is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Diagenode. The 510(k) number is K181156.

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

Panther Fusion GBS Assay received FDA 510(k) clearance on 2018-07-27, under 510(k) number K181156.

Who is the listed applicant for Panther Fusion GBS Assay?

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

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

The FDA product code for Panther Fusion GBS Assay is NJR.

Related Devices (Code: NJR)

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.

K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheid K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC K173725NeuMoDx GBS AssayNeumodx Molecular, Inc.K173250Solana GBS AssayQuidel Corporation K170557GenePOC GBS LBGenepoc, Inc.

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.