Device Listing 2068079447

Listing Summary#

Listing key
2068079447
Premarket submission
K181551
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
Applicant
Runbio Biotech Co.,Ltd
Product code
LCX
Decision date
2019-02-22