FDA 510(k)

One Step Pregnancy Test

K-Number: K210341 · 2022-03-10

ApplicantSpd Swiss Precision Diagnostics GmbH

Decision Date2022-03-10

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

One Step Pregnancy Test is a medical device manufactured by Spd Swiss Precision Diagnostics GmbH. It received FDA 510(k) clearance on 2022-03-10 under approval number K210341. 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 Pregnancy Test?

One Step Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Spd Swiss Precision Diagnostics GmbH. The 510(k) number is K210341.

When was One Step Pregnancy Test approved by the FDA?

One Step Pregnancy Test received FDA 510(k) clearance on 2022-03-10, under approval number K210341.

What company makes One Step Pregnancy Test?

One Step Pregnancy Test is manufactured by Spd Swiss Precision Diagnostics GmbH.

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

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

Other Devices by Spd Swiss Precision Diagnostics GmbH

K200913Clearblue® Early Digital Pregnancy Test K213379Clearblue ® Early Pregnancy Test K240025Clearblue® Early Detection Pregnancy Test

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.