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510(k) K910481

Device
EPO-RIA
Applicant
RAMCO LABORATORIES, INC.
510(k) number
K910481
Product code
GGT  
Decision
Substantially Equivalent (SESE)
Decision date
1991-11-29
Date received
1991-02-06
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
CANDICE GORIN
Address
4507 Mt.Vernon Houston TX US 77006 77006

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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