Cleared Traditional

EARLYDETECT MENOPAUSE TEST FOR FSH

K030058 · Early Detect, Inc. · Chemistry

Jul 2003

Decision

204d

Days

Class 1

Risk

About This 510(k) Submission

K030058 is an FDA 510(k) clearance for the EARLYDETECT MENOPAUSE TEST FOR FSH, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Early Detect, Inc. (Orange, US). The FDA issued a Cleared decision on July 30, 2003, 204 days after receiving the submission on January 7, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number	K030058 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 07, 2003
Decision Date	July 30, 2003
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement