Cleared Traditional

ONE STEP FSH MENOPAUSAL TEST

K052662 · Ind Diagnostic, Inc. · Chemistry
Nov 2005
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K052662 is an FDA 510(k) clearance for the ONE STEP FSH MENOPAUSAL TEST, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on November 30, 2005, 64 days after receiving the submission on September 27, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K052662 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2005
Decision Date November 30, 2005
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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