K152470

Substantially Equivalent

Great Basin Staph ID/R Blood Culture Panel

Applicant: Great Basin Scientific, Inc.
Product 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

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.