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510(k) K002450

GENUA MENOPAUSE MONITOR TEST KIT by Genua 1944, Inc. — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2001
Date Received
August 9, 2000
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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  • K964693 — ELECSYS FSH ASSAY (December 16, 1996)
  • K962118 — DSL ACTIVE FSH IRMA (September 9, 1996)