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510(k) K893393

Device
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
Applicant
INCSTAR CORP.
510(k) number
K893393
Product code
GGT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-21
Date received
1989-05-01
Regulation
864.7250
Classification name
Assay, Erythropoietin
Medical specialty
Hematology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
G TALLAS
Address
1990 Insustrial Blvd. P.O. Box 285 Stillwater MN US 55082 55082

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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