510(k) K181551

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 by Runbio Biotech Co.,Ltd — Product Code LCX

K181551 is an FDA 510(k) premarket notification submitted by Runbio Biotech Co.,Ltd for the device "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". The FDA issued a decision of Substantially Equivalent on Feb 22, 2019. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Runbio Biotech Co.,Ltd has 2 other 510(k) clearances on record.