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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 the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) 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. The listed applicant is Microbiologics, Inc.. The 510(k) number is K182472.

When did Cepheid Xpert GBS LB Control Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for Cepheid Xpert GBS LB Control Panel?

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

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.

Other records listing Microbiologics, 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.

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Related Devices (Code: PMN)

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.

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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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