Cleared Traditional

FIRST RESPONSE PREGNANCY TEST

K030258 · Armkel, LLC · Chemistry
Feb 2003
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K030258 is an FDA 510(k) clearance for the FIRST RESPONSE 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 February 25, 2003, 32 days after receiving the submission on January 24, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K030258 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2003
Decision Date February 25, 2003
Days to Decision 32 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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