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FDA 510(k)

Cepheid Xpert GBS LB Control Panel

K-Number: K182472 · 2018-11-08

ApplicantMicrobiologics, Inc.
Decision Date2018-11-08
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cepheid Xpert GBS LB Control Panel is a medical device manufactured by Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-11-08 under approval number K182472. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cepheid Xpert GBS LB Control Panel?

Cepheid Xpert GBS LB Control Panel is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Microbiologics, Inc.. The 510(k) number is K182472.

When was Cepheid Xpert GBS LB Control Panel approved by the FDA?

Cepheid Xpert GBS LB Control Panel received FDA 510(k) clearance on 2018-11-08, under approval number K182472.

What company makes Cepheid Xpert GBS LB Control Panel?

Cepheid Xpert GBS LB Control Panel is manufactured by Microbiologics, Inc..

What is the FDA product code for Cepheid Xpert GBS LB Control Panel?

The FDA product code for Cepheid Xpert GBS LB Control Panel is PMN.

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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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