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510(k) K932650

ERYTHROPOIETIN IMMUNOASSAY KIT by Nichols Institute — Product Code GGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
June 2, 1993
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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