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FDA 510(k)

Great Basin Stool Bacterial Pathogens Panel

K-Number: K163571 · 2017-07-12

ApplicantGreat Basin Scientific, Inc.
Decision Date2017-07-12
Product CodePCI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Great Basin Stool Bacterial Pathogens Panel is the device name listed in this FDA 510(k) record. The listed applicant is Great Basin Scientific, Inc.. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K163571. The device is classified under product code PCI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Great Basin Stool Bacterial Pathogens Panel?

Great Basin Stool Bacterial Pathogens Panel is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Great Basin Scientific, Inc.. The 510(k) number is K163571.

When did Great Basin Stool Bacterial Pathogens Panel receive FDA 510(k) clearance?

Great Basin Stool Bacterial Pathogens Panel received FDA 510(k) clearance on 2017-07-12, under 510(k) number K163571.

Who is the listed applicant for Great Basin Stool Bacterial Pathogens Panel?

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

What is the FDA product code for Great Basin Stool Bacterial Pathogens Panel?

The FDA product code for Great Basin Stool Bacterial Pathogens Panel is PCI.

Related Clinical Trials

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.

NCT04826991Wells and Enteric Disease TransmissionACTIVE_NOT_RECRUITING

Other records listing Great Basin Scientific, 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.

K170284Great Basin Bordetella Direct TestK152470Great Basin Staph ID/R Blood Culture PanelK152955Great Basin Shiga Toxin Direct Test

Related Devices (Code: PCI)

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.

K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR SystemBecton, Dickinson and CompanyK214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and CompanyK173330PanNAT STEC TestMicronics, 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.

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