Cleared Traditional

ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)

K941713 · Ortho Diagnostic Systems, Inc. · Hematology
Apr 1995
Decision
419d
Days
Class 2
Risk

About This 510(k) Submission

K941713 is an FDA 510(k) clearance for the ORTHO-MUNE 0KT 11 (CD2) 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 April 26, 1995, 419 days after receiving the submission on March 3, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K941713 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1994
Decision Date April 26, 1995
Days to Decision 419 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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