Great Basin Staph ID/R Blood Culture Panel— 510(k) K152470

Substantially Equivalent

Great Basin Scientific, Inc.

FDA 510(k) clearance K152470 for Great Basin Staph ID/R Blood Culture Panel, Substantially Equivalent on 2016-03-25. Applicant: Great Basin Scientific, Inc..

Clearance details

Applicant: Great Basin Scientific, Inc.
Product code: Code PAM
Advisory panel: Microbiology
Date received: 2015-08-31
Decision date: 2016-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code PAM

product code PAM

Death: 6
Malfunction: 598
Total: 604

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.