RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST— 510(k) K081150

Name: FDA 510(k) clearance K081150
Creator: U.S. Food and Drug Administration
Published: 2009-06-16

Substantially Equivalent

Turklab Medical Devices, Inc.

FDA 510(k) clearance K081150 for RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST, Substantially Equivalent on 2009-06-16. Applicant: Turklab Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Turklab Medical Devices, Inc.
Product code: Product code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2008-04-23
Decision date: 2009-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Izmir,, TR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.