Cleared Traditional

ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)

K950625 · Ortho Diagnostic Systems, Inc. · Hematology
May 1996
Decision
458d
Days
Class 2
Risk

About This 510(k) Submission

K950625 is an FDA 510(k) clearance for the ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE), a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on May 13, 1996, 458 days after receiving the submission on February 10, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K950625 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1995
Decision Date May 13, 1996
Days to Decision 458 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220

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