VERSATREK MYCO PZA KIT— 510(k) K052323

Substantially Equivalent

Trek Diagnostic Systems, Inc.

FDA 510(k) clearance K052323 for VERSATREK MYCO PZA KIT, Substantially Equivalent on 2006-01-19. Applicant: Trek Diagnostic Systems, Inc..

Clearance details

Applicant: Trek Diagnostic Systems, Inc.
Product code: Code MJA
Advisory panel: Microbiology
Date received: 2005-08-25
Decision date: 2006-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sun Prairie, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJA

product code MJA

Malfunction: 827
Total: 827

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.