VERSATREK— 510(k) K032306

Substantially Equivalent

Trek Diagnostic Systems, Inc.

FDA 510(k) clearance K032306 for VERSATREK, Substantially Equivalent on 2003-08-22. Applicant: Trek Diagnostic Systems, Inc..

Clearance details

Applicant: Trek Diagnostic Systems, Inc.
Product code: Code MDB
Advisory panel: Microbiology
Date received: 2003-07-25
Decision date: 2003-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

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.