Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cepheid Xpert Respiratory Control Panel

K-Number: K190086 · 2019-10-07

ApplicantMicrobiologics, Inc.
Decision Date2019-10-07
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cepheid Xpert Respiratory 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 2019-10-07 under 510(k) number K190086. 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 Respiratory Control Panel?

Cepheid Xpert Respiratory Control Panel is a medical device that received FDA 510(k) clearance on 2019-10-07. The listed applicant is Microbiologics, Inc.. The 510(k) number is K190086.

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

Cepheid Xpert Respiratory Control Panel received FDA 510(k) clearance on 2019-10-07, under 510(k) number K190086.

Who is the listed applicant for Cepheid Xpert Respiratory 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 Respiratory Control Panel?

The FDA product code for Cepheid Xpert Respiratory 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.

K191168Cepheid Xpert SA Nasal Complete Control PanelK191172Cepheid Xpert MRSA NxG Control PanelK190223Cepheid Xpert CT/NG Control PanelK190463Cepheid Xpert C. difficile/Epi Control PanelK182472Cepheid Xpert GBS LB Control PanelK181683BD MAX CT/GC/TV 20-Day QC Panel

View all 8 devices →

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.

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLCK260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLCK254166MDx-Chex for BCNStreckK254167MDx-Chex for BCYStreck, LLCK251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.

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.

↑