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FDA 510(k)

Great Basin Bordetella Direct Test

K-Number: K170284 · 2017-03-31

ApplicantGreat Basin Scientific, Inc.
Decision Date2017-03-31
Product CodeOZZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Great Basin Bordetella Direct Test 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 2017-03-31 under 510(k) number K170284. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Great Basin Bordetella Direct Test?

Great Basin Bordetella Direct Test is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Great Basin Scientific, Inc.. The 510(k) number is K170284.

When did Great Basin Bordetella Direct Test receive FDA 510(k) clearance?

Great Basin Bordetella Direct Test received FDA 510(k) clearance on 2017-03-31, under 510(k) number K170284.

Who is the listed applicant for Great Basin Bordetella Direct Test?

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 Bordetella Direct Test?

The FDA product code for Great Basin Bordetella Direct Test is OZZ.

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 PanelK152470Great Basin Staph ID/R Blood Culture PanelK152955Great Basin Shiga Toxin Direct Test

Related Devices (Code: OZZ)

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.

K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK181029Solana Bordetella Complete AssayQuidel CorporationK163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation

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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