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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 a medical device manufactured by Great Basin Scientific, Inc.. It received FDA 510(k) clearance on 2017-07-12 under approval 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. It is manufactured by Great Basin Scientific, Inc.. The 510(k) number is K163571.

When was Great Basin Stool Bacterial Pathogens Panel approved by the FDA?

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

What company makes Great Basin Stool Bacterial Pathogens Panel?

Great Basin Stool Bacterial Pathogens Panel is manufactured by Great Basin Scientific, Inc..

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 PubMed Literature

PMID: 41212219 Biosurfactants as novel antibiofilm agents: mechanisms, biomedical applications, and applications in biofilm-associated infections. Archives of microbiology (2025)

Other Devices by Great Basin Scientific, Inc.

K152470Great Basin Staph ID/R Blood Culture Panel K152955Great Basin Shiga Toxin Direct Test K170284Great Basin Bordetella Direct Test

Related Devices (Code: PCI)

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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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