Cleared Traditional

ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)

K932530 · Ortho Diagnostic Systems, Inc. · Hematology
Apr 1995
Decision
708d
Days
Class 2
Risk

About This 510(k) Submission

K932530 is an FDA 510(k) clearance for the ORTHO-MUNE OKT 3 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, 708 days after receiving the submission on May 18, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K932530 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1993
Decision Date April 26, 1995
Days to Decision 708 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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