TRAX(TM) CD4 TEST KIT— 510(k) K925255

Substantially Equivalent

T Cell Diagnostics, Inc.

FDA 510(k) clearance K925255 for TRAX(TM) CD4 TEST KIT, Substantially Equivalent on 1995-05-15. Applicant: T Cell Diagnostics, Inc..

Clearance details

Applicant: T Cell Diagnostics, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1992-10-19
Decision date: 1995-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

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.