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)

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

K-Number: K181711 · 2018-08-15

ApplicantMicrobiologics, Inc.
Decision Date2018-08-15
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is a medical device manufactured by Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-08-15 under approval number K181711. 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 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is a medical device that received FDA 510(k) clearance on 2018-08-15. It is manufactured by Microbiologics, Inc.. The 510(k) number is K181711.

When was BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel approved by the FDA?

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel received FDA 510(k) clearance on 2018-08-15, under approval number K181711.

What company makes BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is manufactured by Microbiologics, Inc..

What is the FDA product code for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

The FDA product code for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is PMN.

Related Clinical Trials

NCT06984484 Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease RECRUITING NCT06681012 Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome RECRUITING

Other Devices by Microbiologics, Inc.

K182472Cepheid Xpert GBS LB Control Panel K181683BD MAX CT/GC/TV 20-Day QC Panel K190086Cepheid Xpert Respiratory Control 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.

↑