ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)— 510(k) K950482

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K950482 for ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE), Substantially Equivalent on 1996-05-10. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1995-02-03
Decision date: 1996-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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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.