510(k) K172627 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
| Applicant | Runbio Biotech Co.,Ltd, Shantou, CN |
| Decision | Substantially Equivalent, Mar 28, 2018 |
| Received | Sep 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172627
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.