Cleared Traditional

ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE

K964754 · Ortho Diagnostic Systems, Inc. · Hematology
Jan 1997
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K964754 is an FDA 510(k) clearance for the ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE 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 January 22, 1997, 56 days after receiving the submission on November 27, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K964754 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 1996
Decision Date January 22, 1997
Days to Decision 56 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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