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FDA 510(k)

Panther Fusion GBS Assay

K-Number: K181156 · 2018-07-27

ApplicantDiagenode
Decision Date2018-07-27
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Panther Fusion GBS Assay is a medical device manufactured by Diagenode. It received FDA 510(k) clearance on 2018-07-27 under approval 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. It is manufactured by Diagenode. The 510(k) number is K181156.

When was Panther Fusion GBS Assay approved by the FDA?

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

What company makes Panther Fusion GBS Assay?

Panther Fusion GBS Assay is manufactured by Diagenode.

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

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

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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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