Cleared Traditional

ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM

K935720 · Ortho Diagnostic Systems, Inc. · Hematology
May 1996
Decision
891d
Days
Class 2
Risk

About This 510(k) Submission

K935720 is an FDA 510(k) clearance for the ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER 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 May 9, 1996, 891 days after receiving the submission on November 30, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K935720 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1993
Decision Date May 09, 1996
Days to Decision 891 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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