Cleared Traditional

PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112

K040575 · Phamatech, Inc. · Chemistry
May 2004
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K040575 is an FDA 510(k) clearance for the PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112, 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 May 20, 2004, 77 days after receiving the submission on March 4, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K040575 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2004
Decision Date May 20, 2004
Days to Decision 77 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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