510(k) K172257 ยท JHI Visual, Pregnancy Hcg, Prescription Use
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
| Applicant | True Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 22, 2017 |
| Received | Jul 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172257
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.