Cleared Traditional

ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE

K951459 · Ortho Diagnostic Systems, Inc. · Hematology
Jul 1997
Decision
837d
Days
Class 2
Risk

About This 510(k) Submission

K951459 is an FDA 510(k) clearance for the ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE, 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 July 14, 1997, 837 days after receiving the submission on March 30, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K951459 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1995
Decision Date July 14, 1997
Days to Decision 837 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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