Cleared Traditional

LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA

K040923 · Ibl GmbH · Chemistry
Jul 2004
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K040923 is an FDA 510(k) clearance for the LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA, a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on July 22, 2004, 105 days after receiving the submission on April 8, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K040923 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2004
Decision Date July 22, 2004
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLS — Radioimmunoassay, Progesterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1620

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