Cleared Traditional

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM

K041349 · Ibl GmbH · Chemistry
Sep 2004
Decision
127d
Days
Class 1
Risk

About This 510(k) Submission

K041349 is an FDA 510(k) clearance for the LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM, a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on September 24, 2004, 127 days after receiving the submission on May 20, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number K041349 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2004
Decision Date September 24, 2004
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHP — Radioimmunoassay, Estradiol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1260

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