SAS STREPALERT— 510(k) K013379

Name: FDA 510(k) clearance K013379
Creator: U.S. Food and Drug Administration
Published: 2001-12-12

Substantially Equivalent

Sa Scientific, Inc.

FDA 510(k) clearance K013379 for SAS STREPALERT, Substantially Equivalent on 2001-12-12. Applicant: Sa Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Sa Scientific, Inc.
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2001-10-12
Decision date: 2001-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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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.