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 the device name listed in this FDA 510(k) record. The listed applicant is Genepoc, Inc.. It received FDA 510(k) clearance on 2017-05-25 under 510(k) 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. The listed applicant is Genepoc, Inc.. The 510(k) number is K170557.

When did GenePOC GBS LB receive FDA 510(k) clearance?

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

Who is the listed applicant for GenePOC GBS LB?

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

What is the FDA product code for GenePOC GBS LB?

The FDA product code for GenePOC GBS LB is NJR.

Other records listing Genepoc, Inc. as applicant

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.

K190275GenePOC Carba K183366GenePOC Strep A K172569GenePOC CDiff K170558revogene

Related Devices (Code: NJR)

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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.