510(k) K203246 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
| Applicant | Atlas Link Technology Co., Ltd., Langfang, CN |
| Decision | Substantially Equivalent, Aug 4, 2021 |
| Received | Nov 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203246
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.