Cleared Traditional

TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA

K990172 · Coulter Corp. · Hematology

Apr 1999

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K990172 is an FDA 510(k) clearance for the TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on April 13, 1999, 84 days after receiving the submission on January 19, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K990172 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 1999
Decision Date	April 13, 1999
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF