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510(k) K790282

Device
ELDONCARD
Applicant
NORDISK INFUSER SYSTEM
510(k) number
K790282
Product code
KSZ  
Decision
Substantially Equivalent (SESE)
Decision date
1979-05-04
Date received
1979-02-13
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
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K771098BLOOD GROUPING SYS., BG-9Technicon Instruments Corp.1977-08-04
K770185RH CONTROL DILUENTBd Becton Dickinson Vacutainer Systems Preanalytic1977-03-14

Legacy Summary#

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FDA Review#

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