GENUA MENOPAUSE MONITOR TEST KIT— 510(k) K002450

Name: FDA 510(k) clearance K002450
Creator: U.S. Food and Drug Administration
Published: 2001-01-12

Substantially Equivalent

Genua 1944, Inc.

FDA 510(k) clearance K002450 for GENUA MENOPAUSE MONITOR TEST KIT, Substantially Equivalent on 2001-01-12. Applicant: Genua 1944, Inc.. Device class: 1.

Clearance details

Applicant: Genua 1944, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 2000-08-09
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blairstown, NJ, US

Download summary PDF View on FDA.gov ↗

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