Cleared Traditional

FSH MENOPAUSE PREDICTOR TEST

K041165 · ACON Laboratories, Inc. · Chemistry
Jun 2004
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K041165 is an FDA 510(k) clearance for the FSH MENOPAUSE PREDICTOR TEST, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by ACON Laboratories, Inc. (Beverly, US). The FDA issued a Cleared decision on June 17, 2004, 44 days after receiving the submission on May 4, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K041165 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2004
Decision Date June 17, 2004
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGJ — Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1300

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