CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC— 510(k) K910473

Substantially Equivalent

Coulter Immunology

FDA 510(k) clearance K910473 for CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC, Substantially Equivalent on 1991-10-31. Applicant: Coulter Immunology.

Clearance details

Applicant: Coulter Immunology
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1991-02-04
Decision date: 1991-10-31
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.