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FDA 510(k)

Great Basin Staph ID/R Blood Culture Panel

K-Number: K152470 · 2016-03-25

ApplicantGreat Basin Scientific, Inc.
Decision Date2016-03-25
Product CodePAM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Great Basin Staph ID/R Blood Culture 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 2016-03-25 under 510(k) number K152470. The device is classified under product code PAM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Great Basin Staph ID/R Blood Culture Panel?

Great Basin Staph ID/R Blood Culture Panel is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Great Basin Scientific, Inc.. The 510(k) number is K152470.

When did Great Basin Staph ID/R Blood Culture Panel receive FDA 510(k) clearance?

Great Basin Staph ID/R Blood Culture Panel received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152470.

Who is the listed applicant for Great Basin Staph ID/R Blood Culture 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 Staph ID/R Blood Culture Panel?

The FDA product code for Great Basin Staph ID/R Blood Culture Panel is PAM.

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.

K163571Great Basin Stool Bacterial Pathogens PanelK170284Great Basin Bordetella Direct TestK152955Great Basin Shiga Toxin Direct Test

Related Devices (Code: PAM)

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.

K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbHK243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex CorporationK181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, IncorporatedK163390iC-GPC Assay TM for use on the iC-SystemTMIcubate, 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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