Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0— 510(k) K234091

Substantially Equivalent

Genalyte, Inc.

FDA 510(k) clearance K234091 for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0, Substantially Equivalent on 2024-07-22. Applicant: Genalyte, Inc..

Clearance details

Applicant: Genalyte, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2023-12-26
Decision date: 2024-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.