Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Runbio Biotech Co.,Ltd

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
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 CassetteLCX2019-02-22 View
510(k) K172627 David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteLCX2018-03-28 View
510(k) K053236 DAVID PREGNANCY TEST (MIDSTREAM)LCX2006-07-18 View
↑