Cleared Traditional

WUNDER PREGNANCY TEST

K130456 · James Nguyen · Chemistry
Apr 2014
Decision
410d
Days
Class 2
Risk

About This 510(k) Submission

K130456 is an FDA 510(k) clearance for the WUNDER PREGNANCY TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by James Nguyen (San Jose, US). The FDA issued a Cleared decision on April 8, 2014, 410 days after receiving the submission on February 22, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K130456 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2013
Decision Date April 08, 2014
Days to Decision 410 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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