Cleared Traditional

IMMULITE(R) FSH

K921704 · Cirrus Diagnostics, Inc. · Chemistry
Jun 1992
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K921704 is an FDA 510(k) clearance for the IMMULITE(R) FSH, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on June 9, 1992, 60 days after receiving the submission on April 10, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K921704 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1992
Decision Date June 09, 1992
Days to Decision 60 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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