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510(k) K840902

ENDAB ESTRIOL UNCONJUGATED by Immunotech Corp. — Product Code CGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1984
Date Received
February 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estriol
Device Class
Class I
Regulation Number
862.1265
Review Panel
CH
Submission Type

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