510(k) K211759— Selux AST System; Model AST Gen 1.0

Substantially Equivalent

Selux Diagnostics, Inc.

Clearance details

Applicant: Selux Diagnostics, Inc.
Product code: Code LON
Advisory panel: Microbiology
Date received: 2021-06-07
Decision date: 2023-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlestown, MA, US

Adverse events under product code LON

product code LON

Malfunction: 2,383
Total: 2,383

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.