Cleared Special

MOMENTS MENOPAUSE CHECK, MODEL 9113

K043599 · Phamatech, Inc. · Chemistry
Feb 2005
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K043599 is an FDA 510(k) clearance for the MOMENTS MENOPAUSE CHECK, MODEL 9113, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 25, 2005, 58 days after receiving the submission on December 29, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K043599 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2004
Decision Date February 25, 2005
Days to Decision 58 days
Submission Type Special
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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