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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 K181551
Device Name DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
Applicant
Runbio BioTech Co.,Ltd
Rongsheng Technological Zone, University Road
Shantou,  CN 515063
Applicant Contact Lyn Chen
Correspondent
Runbio BioTech Co.,Ltd
Rongsheng Technological Zone, University Road
Shantou,  CN 515063
Correspondent Contact Lyn Chen
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received06/13/2018
Decision Date 02/22/2019
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
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