Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Microbiologics, Inc.. It received FDA 510(k) clearance on 2019-10-07 under approval 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. It is manufactured by Microbiologics, Inc.. The 510(k) number is K190086.

When was Cepheid Xpert Respiratory Control Panel approved by the FDA?

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

What company makes Cepheid Xpert Respiratory Control Panel?

Cepheid Xpert Respiratory Control Panel is manufactured by Microbiologics, Inc..

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

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

Related Clinical Trials

NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT05881304 Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC COMPLETED NCT07610447 VR vs Treadmill Exercise in Children With Asthma RECRUITING NCT06671015 A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure RECRUITING NCT07610811 Foot Reflexology and Massage in Neonates Receiving Phototherapy NOT_YET_RECRUITING NCT07160868 Obstructive Sleep Apnoea and Difficult Asthma (OSADA) RECRUITING

Other Devices by Microbiologics, Inc.

K182472Cepheid Xpert GBS LB Control Panel K181683BD MAX CT/GC/TV 20-Day QC Panel K181711BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel K191168Cepheid Xpert SA Nasal Complete Control Panel K191172Cepheid Xpert MRSA NxG Control Panel K190223Cepheid Xpert CT/NG Control Panel

View all 8 devices →

Related Devices (Code: PMN)

K161573FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakBio-Rad Laboratories DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPakBio-Rad Laboratories K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, 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.

↑