FDA 510(k)

GenePOC GBS LB

K-Number: K170557 · 2017-05-25

Decision Date2017-05-25

Product CodeNJR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GenePOC GBS LB is a medical device manufactured by Genepoc, Inc.. It received FDA 510(k) clearance on 2017-05-25 under approval number K170557. 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 GenePOC GBS LB?

GenePOC GBS LB is a medical device that received FDA 510(k) clearance on 2017-05-25. It is manufactured by Genepoc, Inc.. The 510(k) number is K170557.

When was GenePOC GBS LB approved by the FDA?

GenePOC GBS LB received FDA 510(k) clearance on 2017-05-25, under approval number K170557.

What company makes GenePOC GBS LB?

GenePOC GBS LB is manufactured by Genepoc, Inc..

What is the FDA product code for GenePOC GBS LB?

The FDA product code for GenePOC GBS LB is NJR.

Other Devices by Genepoc, Inc.

K172569GenePOC CDiff K170558revogene K190275GenePOC Carba K183366GenePOC Strep A

Related Devices (Code: NJR)

K162772ARIES GBS AssayLuminex Corporation K173250Solana GBS AssayQuidel Corporation K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC K181156Panther Fusion GBS AssayDiagenode K173725NeuMoDx GBS AssayNeumodx Molecular, Inc. K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

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.