FDA.reportPublic FDA data

510(k) K771098

Device
BLOOD GROUPING SYS., BG-9
Applicant
Technicon Instruments Corp.
510(k) number
K771098
Product code
KSZ
Decision
Substantially Equivalent (SESE)
Decision date
1977-08-04
Date received
1977-06-20
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
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K770185RH CONTROL DILUENTBd Becton Dickinson Vacutainer Systems Preanalytic1977-03-14