MONOCLONAL MOUSE ANTI-HUMAN T-CELL— 510(k) K942797

Substantially Equivalent

Dako Corp.

FDA 510(k) clearance K942797 for MONOCLONAL MOUSE ANTI-HUMAN T-CELL, Substantially Equivalent on 1994-11-10. Applicant: Dako Corp..

Clearance details

Applicant: Dako Corp.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1994-06-15
Decision date: 1994-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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.