510(k) K190705 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
| Applicant | Wholepower Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Apr 15, 2019 |
| Received | Mar 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190705
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.