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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK103574
Test Name Verify Diagnostics Inc., Make a Baby Pregnancy Test Midstream  
Manufacturer NameLehnus & Associates Consulting
Consumer Information Phone Number(866)446-2953
Test TypeUrine hCG by visual color comparison tests
Effective Date03/05/2020
Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K103574
Device Name PREGNANCY ONE STEP RAPID TEST
Applicant
Lehnus & Associates Consulting
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301 -8804
Applicant Contact Gary Lehnus
Correspondent
Lehnus & Associates Consulting
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301 -8804
Correspondent Contact Gary Lehnus
Regulation Number862.1155
Classification Product Code
LCX  
Date Received12/06/2010
Decision Date 07/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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