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510(k) K893393

EPO-TRAC BY RADIOIMMUNOASSAY (RIA) by Incstar Corp. — Product Code GGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1989
Date Received
May 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Erythropoietin
Device Class
Class II
Regulation Number
864.7250
Review Panel
HE
Submission Type

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