ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING— 510(k) K972772

Substantially Equivalent

Trek Diagnostic Systems, Inc.

FDA 510(k) clearance K972772 for ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING, Substantially Equivalent on 1999-07-13. Applicant: Trek Diagnostic Systems, Inc..

Clearance details

Applicant: Trek Diagnostic Systems, Inc.
Product code: Code MJA
Advisory panel: Microbiology
Date received: 1997-07-24
Decision date: 1999-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

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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.