Cleared Traditional

FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

K040866 · Armkel, LLC · Chemistry
Oct 2004
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K040866 is an FDA 510(k) clearance for the FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Armkel, LLC (Princeton, US). The FDA issued a Cleared decision on October 19, 2004, 200 days after receiving the submission on April 2, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K040866 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2004
Decision Date October 19, 2004
Days to Decision 200 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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