K013379

Substantially Equivalent

SAS STREPALERT

Applicant: Sa Scientific, Inc.
Product code: GTY
Advisory panel: Microbiology
Date received: 2001-10-12
Decision date: 2001-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

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.