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510(k) K952559

Device
ERYTHROPOIETIN IMMUNOASSAY KIT
Applicant
NICHOLS INSTITUTE
510(k) number
K952559
Product code
GGT  
Decision
Substantially Equivalent (SESE)
Decision date
1996-05-29
Date received
1995-06-02
Regulation
864.7250
Classification name
Assay, Erythropoietin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVE D SMITH
Address
33608 Ortega Hwy. San Juan Capistrano CA US 92690 92690

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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