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510(k) K901345

MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 by Medix Biotech, Inc. — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1990
Date Received
March 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
Device Class
Class I
Regulation Number
862.1300
Review Panel
CH
Submission Type

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