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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 a medical device manufactured by Great Basin Scientific, Inc.. It received FDA 510(k) clearance on 2016-03-25 under approval 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. It is manufactured by Great Basin Scientific, Inc.. The 510(k) number is K152470.

When was Great Basin Staph ID/R Blood Culture Panel approved by the FDA?

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

What company makes Great Basin Staph ID/R Blood Culture Panel?

Great Basin Staph ID/R Blood Culture Panel is manufactured by Great Basin Scientific, Inc..

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.

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Related Devices (Code: PAM)

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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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