PREGNANCY ONE STEP RAPID TEST— 510(k) K103574

Name: FDA 510(k) clearance K103574
Creator: U.S. Food and Drug Administration
Published: 2011-07-28

Substantially Equivalent

Lehnus & Associates Consulting

FDA 510(k) clearance K103574 for PREGNANCY ONE STEP RAPID TEST, Substantially Equivalent on 2011-07-28. Applicant: Lehnus & Associates Consulting. Device class: 2.

Clearance details

Applicant: Lehnus & Associates Consulting
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2010-12-06
Decision date: 2011-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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