FDA.reportPublic FDA data

510(k) K131301

Device
BD FACS SAMPLE PREP ASSISTANT III
Applicant
BECTON DICKINSON & CO.
510(k) number
K131301
Product code
PER  
Decision
Substantially Equivalent (SESE)
Decision date
2013-08-02
Date received
2013-05-07
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

Applicant Contact#

Contact
KIMBERLY LIEDTKE
Address
2350 Qume Dr. San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PER  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130253TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATIONBeckman Coulter, Inc.2013-07-15
K050191MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWAREBecton, Dickinson & CO2005-02-22

Legacy Summary#

summary

FDA Review#

Decision Summary