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510(k) K926390

Device
PREDICTA ERYTHROPOIETIN KIT
Applicant
GENZYME CORP.
510(k) number
K926390
Product code
GGT  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-25
Date received
1992-12-22
Regulation
864.7250
Classification name
Assay, Erythropoietin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ALODIA M RUIZ
Address
One Kendall Sq. Cambridge MA US 02139 02139

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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