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FDA 510(k)

Clearblue® Early Digital Pregnancy Test

K-Number: K200913 · 2021-08-13

ApplicantSpd Swiss Precision Diagnostics GmbH
Decision Date2021-08-13
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Clearblue® Early Digital Pregnancy Test is a medical device manufactured by Spd Swiss Precision Diagnostics GmbH. It received FDA 510(k) clearance on 2021-08-13 under approval number K200913. 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 Clearblue® Early Digital Pregnancy Test?

Clearblue® Early Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Spd Swiss Precision Diagnostics GmbH. The 510(k) number is K200913.

When was Clearblue® Early Digital Pregnancy Test approved by the FDA?

Clearblue® Early Digital Pregnancy Test received FDA 510(k) clearance on 2021-08-13, under approval number K200913.

What company makes Clearblue® Early Digital Pregnancy Test?

Clearblue® Early Digital Pregnancy Test is manufactured by Spd Swiss Precision Diagnostics GmbH.

What is the FDA product code for Clearblue® Early Digital Pregnancy Test?

The FDA product code for Clearblue® Early Digital Pregnancy Test is LCX.

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Related PubMed Literature

PMID: 42145202 Fertile-window misclassification in period-tracking applications and associated pregnancy risk: a large observational analysis. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (2026) PMID: 41032887 Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study. Journal of medical Internet research (2025) PMID: 40380731 Effective Requirements Engineering in Early-Stage Digital Health Startups. Studies in health technology and informatics (2025) PMID: 40271230 When Software Becomes Medicine: Ignoring It May Soon Be Malpractice. Cureus (2025)

Other Devices by Spd Swiss Precision Diagnostics GmbH

K213379Clearblue ® Early Pregnancy Test K210341One Step 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

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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