ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001— 510(k) K102760

Name: FDA 510(k) clearance K102760
Creator: U.S. Food and Drug Administration
Published: 2011-08-03

Substantially Equivalent

Atlas Medical

FDA 510(k) clearance K102760 for ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001, Substantially Equivalent on 2011-08-03. Applicant: Atlas Medical. Device class: 2.

Clearance details

Applicant: Atlas Medical
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2010-09-23
Decision date: 2011-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amman, JO

Download summary PDF View on FDA.gov ↗

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