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510(k) K790767

Device
IMMU-TEK AUTOMATIC CENTRIFUGE
Applicant
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
510(k) number
K790767
Product code
KSN  
Decision
Substantially Equivalent (SESE)
Decision date
1979-05-23
Date received
1979-04-19
Regulation
864.9285
Classification name
Centrifuge, Cell-washing, Automated For Immuno-hematology
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

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

Legacy Summary#

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FDA Review#

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