FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST— 510(k) K040866

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K040866 for FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST, Substantially Equivalent on 2004-10-19. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2004-04-02
Decision date: 2004-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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