K223690
- 510(k) number
- K223690
- Device name
- iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
- Applicant
- Shenzhen Yhlo Biotech Co., Ltd. CN
- Product code
- DHA — System, Test, Human Chorionic Gonadotropin
- Decision date
- 2023-12-11
- Date received
- 2022-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K223690.pdf
Official FDA record: K223690
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.