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510(k) K903359

MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT by Immunotech Corp. — Product Code CGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
July 25, 1990
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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