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FDA 510(k)

Cepheid Xpert SA Nasal Complete Control Panel

K-Number: K191168 · 2019-06-25

ApplicantMicrobiologics, Inc.
Decision Date2019-06-25
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cepheid Xpert SA Nasal Complete Control Panel is a medical device manufactured by Microbiologics, Inc.. It received FDA 510(k) clearance on 2019-06-25 under approval number K191168. 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 SA Nasal Complete Control Panel?

Cepheid Xpert SA Nasal Complete Control Panel is a medical device that received FDA 510(k) clearance on 2019-06-25. It is manufactured by Microbiologics, Inc.. The 510(k) number is K191168.

When was Cepheid Xpert SA Nasal Complete Control Panel approved by the FDA?

Cepheid Xpert SA Nasal Complete Control Panel received FDA 510(k) clearance on 2019-06-25, under approval number K191168.

What company makes Cepheid Xpert SA Nasal Complete Control Panel?

Cepheid Xpert SA Nasal Complete Control Panel is manufactured by Microbiologics, Inc..

What is the FDA product code for Cepheid Xpert SA Nasal Complete Control Panel?

The FDA product code for Cepheid Xpert SA Nasal Complete 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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