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510(k) K041165

FSH MENOPAUSE PREDICTOR TEST by ACON Laboratories, Inc. — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2004
Date Received
May 4, 2004
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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