FDA applicant

Great Basin Scientific, Inc.

Salt Lake City, UT4 decisions2016–20171 recall

FDA records 4 decisions for Great Basin Scientific, Inc. (Salt Lake City, UT) from 2016 to 2017: 4 510(k) clearances. Most are in product codes PCH (Gastrointestinal Pathogen Panel Multiplex…) and PAM (Gram-Positive Bacteria And Their Resistance…). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2016high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016high 1 (2016) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Great Basin Scientific, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Great Basin Scientific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Great”

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

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

Great Basin Scientific, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Great”