510(k) K190341— iC-GN iC-Cassette for use on the iC-System

Substantially Equivalent

Icubate, Inc.

Clearance details

Applicant: Icubate, Inc.
Product code: Code PEN
Advisory panel: Microbiology
Date received: 2019-02-14
Decision date: 2019-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, AL, US

Adverse events under product code PEN

product code PEN

Death: 7
Total: 7

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.