LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA— 510(k) K040923

Name: FDA 510(k) clearance K040923
Creator: U.S. Food and Drug Administration
Published: 2004-07-22

Substantially Equivalent

Ibl GmbH

FDA 510(k) clearance K040923 for LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA, Substantially Equivalent on 2004-07-22. Applicant: Ibl GmbH. Device class: 1.

Clearance details

Applicant: Ibl GmbH
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 2004-04-08
Decision date: 2004-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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K965084 — VIDAS PROESTERONE (PRG) (30 409)1997-01-09

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