FDA 510(k)

ONE STEP HCG URINE PREGNANCY TEST

K-Number: K043443 · 2005-04-08

ApplicantGuangzhou Wondfo Biotech Co., Ltd.

Decision Date2005-04-08

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ONE STEP HCG URINE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2005-04-08 under 510(k) number K043443. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE STEP HCG URINE PREGNANCY TEST?

ONE STEP HCG URINE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2005-04-08. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K043443.

When did ONE STEP HCG URINE PREGNANCY TEST receive FDA 510(k) clearance?

ONE STEP HCG URINE PREGNANCY TEST received FDA 510(k) clearance on 2005-04-08, under 510(k) number K043443.

Who is the listed applicant for ONE STEP HCG URINE PREGNANCY TEST?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE STEP HCG URINE PREGNANCY TEST?

The FDA product code for ONE STEP HCG URINE PREGNANCY TEST is LCX.

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Related Devices (Code: LCX)

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLC K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.