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510(k) K894943

Device
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
Applicant
AMGEN, INC.
510(k) number
K894943
Product code
GGT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-10
Date received
1989-08-03
Regulation
864.7250
Classification name
Assay, Erythropoietin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SARAH SWANSON
Address
1840 De Havilland Thousand Oaks CA US 91320 91320

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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