510(k) K223690 ยท DHA System, Test, Human Chorionic Gonadotropin
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
| Applicant | Shenzhen Yhlo Biotech Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 11, 2023 |
| Received | Dec 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223690
No recall in the FDA data names this 510(k).
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