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FDA 510(k)

hCG One Step Pregnancy Test

K-Number: K212418 · 2022-06-30

ApplicantHealstone Biotech, Inc.
Decision Date2022-06-30
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

hCG One Step Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Healstone Biotech, Inc.. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K212418. 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 hCG One Step Pregnancy Test?

hCG One Step Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Healstone Biotech, Inc.. The 510(k) number is K212418.

When did hCG One Step Pregnancy Test receive FDA 510(k) clearance?

hCG One Step Pregnancy Test received FDA 510(k) clearance on 2022-06-30, under 510(k) number K212418.

Who is the listed applicant for hCG One Step Pregnancy Test?

The FDA 510(k) record lists Healstone Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for hCG One Step Pregnancy Test?

The FDA product code for hCG One Step Pregnancy Test is LCX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07522281Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI CyclesNOT_YET_RECRUITING

Other records listing Healstone Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup RxK191841Accurate Multi Panel Drug Urine Test Cup

Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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., LLCK242135Synthgene 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., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

View on FDA Database →

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

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