Cleared Traditional

GENUA MENOPAUSE MONITOR TEST KIT

K002450 · Genua 1944, Inc. · Chemistry

Jan 2001

Decision

156d

Days

Class 1

Risk

About This 510(k) Submission

K002450 is an FDA 510(k) clearance for the GENUA MENOPAUSE MONITOR TEST KIT, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Genua 1944, Inc. (Blairstown, US). The FDA issued a Cleared decision on January 12, 2001, 156 days after receiving the submission on August 9, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number	K002450 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2000
Decision Date	January 12, 2001
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement