K240242
- 510(k) number
- K240242
- Device name
- HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
- Applicant
- Anhui Deepblue Medical Technology Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-10-11
- Date received
- 2024-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240242.pdf
Official FDA record: K240242
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.