510(k) K150815

Device

BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit

Applicant

Becton, Dickinson And Company

510(k) number

K150815

Product code

PMG  

Decision

Substantially Equivalent (SESE)

Decision date

2015-12-17

Date received

2015-03-27

Regulation

864.5220

Classification name

Automated Multicolor Fluorescent Imaging Cytometric Analysis System

Medical specialty

Hematology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No