Cleared Traditional

TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5

K963263 · Coulter Corp. · Hematology

Jan 1997

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K963263 is an FDA 510(k) clearance for the TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on January 22, 1997, 155 days after receiving the submission on August 20, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K963263 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 1996
Decision Date	January 22, 1997
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF