Cleared Special

FACT PLUS ONE-STEP PREGNANCY TEST KIT

K042280 · Unipath , Ltd. · Chemistry
Sep 2004
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K042280 is an FDA 510(k) clearance for the FACT PLUS ONE-STEP PREGNANCY TEST KIT, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on September 10, 2004, 18 days after receiving the submission on August 23, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K042280 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2004
Decision Date September 10, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

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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