K230741
- 510(k) number
- K230741
- Device name
- Macro & Micro-Test HCG Pregnancy Test Midstream
- Applicant
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2023-10-13
- Date received
- 2023-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K230741.pdf
Official FDA record: K230741
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.