COULTER CLONE T11 MONOCLONAL ANTIBODY— 510(k) K875047

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K875047 for COULTER CLONE T11 MONOCLONAL ANTIBODY, Substantially Equivalent on 1988-03-09. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1987-12-08
Decision date: 1988-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, 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.