510(k) K130253

Device

TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION

Applicant

BECKMAN COULTER, INC.

510(k) number

K130253

Product code

PER  

Decision

Substantially Equivalent (SESE)

Decision date

2013-07-15

Date received

2013-02-01

Regulation

862.2750

Classification name

Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Medical specialty

Clinical Chemistry

Review panel

Immunology

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No