Cleared Traditional

ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)

K951632 · Ortho Diagnostic Systems, Inc. · Hematology
Mar 1997
Decision
699d
Days
Class 2
Risk

About This 510(k) Submission

K951632 is an FDA 510(k) clearance for the ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE 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 March 6, 1997, 699 days after receiving the submission on April 7, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K951632 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1995
Decision Date March 06, 1997
Days to Decision 699 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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