Cleared Traditional

ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)

K951100 · Ortho Diagnostic Systems, Inc. · Hematology
May 1996
Decision
430d
Days
Class 2
Risk

About This 510(k) Submission

K951100 is an FDA 510(k) clearance for the ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL 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, 430 days after receiving the submission on March 10, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K951100 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1995
Decision Date May 13, 1996
Days to Decision 430 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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