Cleared Traditional

ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

K950568 · Ortho Diagnostic Systems, Inc. · Hematology
May 1996
Decision
460d
Days
Class 2
Risk

About This 510(k) Submission

K950568 is an FDA 510(k) clearance for the ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) 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, 460 days after receiving the submission on February 8, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K950568 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1995
Decision Date May 13, 1996
Days to Decision 460 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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