Cleared Traditional

ONE-STEP PREGNANCY TEST

K041273 · W.H.P.M., Inc. · Chemistry
May 2004
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K041273 is an FDA 510(k) clearance for the ONE-STEP PREGNANCY TEST, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on May 20, 2004, 8 days after receiving the submission on May 12, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K041273 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2004
Decision Date May 20, 2004
Days to Decision 8 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

Similar Devices — LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 225
MissLan? Early Detection Digital Pregnancy Test; MissLan? Early Result Digital Pregnancy Test
K251040 · Guangzhou Decheng Biotechnology Co., Ltd. · Sep 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · Hangzhou AllTest Biotech Co., Ltd. · Jul 2025
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
K250117 · Assure Tech., LLC · Feb 2025
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Jan 2025
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
K243573 · Assure Tech., LLC · Jan 2025
iHealth? Early Pregnancy Test; iHealth? Early Pregnancy Test Strip
K241394 · Andon Health Co, Ltd. · Dec 2024

More from W.H.P.M., Inc.

View all
Hemosure Accu-Reader A100
K200754 · OOX · Jun 2022
First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
K210327 · QBF · Aug 2021
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
K171695 · NFT · Feb 2018
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
K160793 · DJR · Aug 2016
First Sign? Drug of Abuse Buprenorphine Cup Test, First Sign? Drug of Abuse Buprenorphine Dip Card Test, First Sign? Drug of Abuse Butalbital Cup Test, First Sign? Drug of Abuse Butalbital Dip Card Test, First Sign? Drug of Abuse Morphine Cup Test, First Sign? Drug of Abuse Morphine Dip Card Test.
K152551 · DJG · Nov 2015