OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES— 510(k) K946335

Substantially Equivalent

Immunotech, Inc.

FDA 510(k) clearance K946335 for OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES, Substantially Equivalent on 1995-10-20. Applicant: Immunotech, Inc..

Clearance details

Applicant: Immunotech, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1994-12-29
Decision date: 1995-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbrook, ME, 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.