Cleared Traditional

K123567 - FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST (FDA 510(k) Clearance)

K123567 · Church & Dwight Co., Inc. · Chemistry device
Sep 2013
Decision
294d
Days
Class 2
Risk

K123567 is an FDA 510(k) clearance for the FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).

Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on September 10, 2013, 294 days after receiving the submission on November 20, 2012.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K123567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2012
Decision Date September 10, 2013
Days to Decision 294 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