Cleared Traditional

ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM

K954570 · Ortho Diagnostic Systems, Inc. · Hematology
Apr 1996
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K954570 is an FDA 510(k) clearance for the ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM, 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 30, 1996, 211 days after receiving the submission on October 2, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K954570 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1995
Decision Date April 30, 1996
Days to Decision 211 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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