510(k) K181551 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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, Shantou, CN |
| Decision | Substantially Equivalent, Feb 22, 2019 |
| Received | Jun 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181551
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.