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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K172257
Device Name TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
Applicant
True Diagnostics, Inc.
2782 Loker Ave. W.
Carlsbad,  CA  92010
Applicant Contact Jerry Lee
Correspondent
Biologics Consulting Group
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Jinjie Hu
Regulation Number862.1155
Classification Product Code
JHI  
Subsequent Product Code
LCX  
Date Received07/26/2017
Decision Date 12/22/2017
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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