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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 K171136
Device Name LIA Pregnancy Test
Applicant
Lia Diagnostics
1015 Chestnut St., Suite 1401
Philadelphia,  PA  19107
Applicant Contact Anna Couturier
Correspondent
Lia Diagnostics
1015 Chestnut St., Suite 1401
Philadelphia,  PA  19107
Correspondent Contact Anna Couturier
Regulation Number862.1155
Classification Product Code
LCX  
Date Received04/17/2017
Decision Date 11/20/2017
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
Predetermined Change
Control Plan Authorized		 No
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