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FDA 510(k)

Clearblue ® Early Pregnancy Test

K-Number: K213379 · 2022-09-21

ApplicantSpd Swiss Precision Diagnostics GmbH
Decision Date2022-09-21
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Clearblue ® Early Pregnancy Test is a medical device manufactured by Spd Swiss Precision Diagnostics GmbH. It received FDA 510(k) clearance on 2022-09-21 under approval number K213379. 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 Pregnancy Test?

Clearblue ® Early Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-09-21. It is manufactured by Spd Swiss Precision Diagnostics GmbH. The 510(k) number is K213379.

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

Clearblue ® Early Pregnancy Test received FDA 510(k) clearance on 2022-09-21, under approval number K213379.

What company makes Clearblue ® Early Pregnancy Test?

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

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

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

Related Clinical Trials

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Other Devices by Spd Swiss Precision Diagnostics GmbH

K200913Clearblue® Early Digital 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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