iC-GPC Assay TM for use on the iC-SystemTM— 510(k) K163390

Substantially Equivalent

Icubate, Inc.

FDA 510(k) clearance K163390 for iC-GPC Assay TM for use on the iC-SystemTM, Substantially Equivalent on 2017-08-08. Applicant: Icubate, Inc..

Clearance details

Applicant: Icubate, Inc.
Product code: Code PAM
Advisory panel: Microbiology
Date received: 2016-12-02
Decision date: 2017-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntsville, AL, US

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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.