510(k) K961701— MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE

Substantially Equivalent

Dako Corp.

Clearance details

Applicant: Dako Corp.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1996-05-02
Decision date: 1996-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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.