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510(k) K770185

Device
RH CONTROL DILUENT
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K770185
Product code
KSZ  
Decision
Substantially Equivalent (SESE)
Decision date
1977-03-14
Date received
1977-01-27
Regulation
864.9175
Classification name
System, Test, Automated Blood Grouping And Antibody
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K810899TECHNICON AUTOGROUPER 16-C SYSTEMTechnicon Instruments Corp.1981-05-05
K790282ELDONCARDNordisk Infuser System1979-05-04
K771098BLOOD GROUPING SYS., BG-9Technicon Instruments Corp.1977-08-04

Legacy Summary#

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FDA Review#

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