510(k) Report

FDA applicant

Great Basin Corporation

Salt Lake City, UT1 decision2015–20150 recalls

FDA records 1 decision for Great Basin Corporation (Salt Lake City, UT) in 2015: 1 510(k) clearance. All are in product code NJR (Nucleic Acid Amplification Assay System, Group…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Great Basin Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Great Basin Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K143312Portrait GBS AssayGreat Basin Corporation · 2015

The one decision as Great Basin Corporation →

Other applicant names beginning “Great”

FDA records each applicant name separately; these may or may not be the same firm.

Great Lakes Orthodontics, Ltd. 13Great Batch Medical 11Great Glove Sdn Bhd 4Great Basin Scientific, Inc. 4Great Glove (China), Inc. 2Great Eastern Lumber Co., Inc. 2Great Glove (Thailand) Co., Ltd. 2Great Field Industries Co., Ltd. 1Great Eco Glove Sdn. Bhd. 1Great Future Works, Ltd. 1Great Lakes Intl. 1Great West Medical Equipment, Inc. 1