FDA 510(k)

hCG One Step Pregnancy Test

K-Number: K212418 · 2022-06-30

Decision Date2022-06-30

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

hCG One Step Pregnancy Test is a medical device manufactured by Healstone Biotech, Inc.. It received FDA 510(k) clearance on 2022-06-30 under approval 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. It is manufactured by Healstone Biotech, Inc.. The 510(k) number is K212418.

When was hCG One Step Pregnancy Test approved by the FDA?

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

What company makes hCG One Step Pregnancy Test?

hCG One Step Pregnancy Test is manufactured by Healstone Biotech, Inc..

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

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

Other Devices by Healstone Biotech, Inc.

K191841Accurate Multi Panel Drug Urine Test Cup K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.

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.