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FDA 510(k)

Clearblue® Early Detection Pregnancy Test

K-Number: K240025 · 2024-01-31

ApplicantSpd Swiss Precision Diagnostics GmbH
Decision Date2024-01-31
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Clearblue® Early Detection Pregnancy Test is a medical device manufactured by Spd Swiss Precision Diagnostics GmbH. It received FDA 510(k) clearance on 2024-01-31 under approval number K240025. 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 Detection Pregnancy Test?

Clearblue® Early Detection Pregnancy Test is a medical device that received FDA 510(k) clearance on 2024-01-31. It is manufactured by Spd Swiss Precision Diagnostics GmbH. The 510(k) number is K240025.

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

Clearblue® Early Detection Pregnancy Test received FDA 510(k) clearance on 2024-01-31, under approval number K240025.

What company makes Clearblue® Early Detection Pregnancy Test?

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

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

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

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Related PubMed Literature

PMID: 41595987 Recent Advances in AI-Driven Mobile Health Enhancing Healthcare-Narrative Insights into Latest Progress. Bioengineering (Basel, Switzerland) (2025) PMID: 40718881 Advancements in materiovigilance: A comprehensive overview. Perspectives in clinical research (2025)

Other Devices by Spd Swiss Precision Diagnostics GmbH

K200913Clearblue® Early Digital Pregnancy Test K213379Clearblue ® Early Pregnancy Test K210341One Step 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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