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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K200913
Device Name Clearblue® Early Digital Pregnancy Test
Applicant
SPD Swiss Precision Diagnostics GmbH
47 Route de St Georges, Petit-Lancey
Geneva,  CH ch-1213
Applicant Contact Joanne Scaife
Correspondent
SPD Development Company
Priory Business Park
Bedford,  GB MK44 3UP
Correspondent Contact Kamila Przedmojska
Regulation Number862.1155
Classification Product Code
LCX  
Date Received04/06/2020
Decision Date 08/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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