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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 K240025
Device Name Clearblue® Early Detection Pregnancy Test
Applicant
SPD Swiss Precision Diagnostics GmbH
Route de St Georges, 47
Petit-Lancy
Geneva,  CH 1213
Applicant Contact Kim French
Correspondent
SPD Development Company Limited
Priory Business Park, Stannard Way
Bedford,  GB MK443UP
Correspondent Contact Kamila Przedmojska
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/03/2024
Decision Date 01/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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