HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)— 510(k) K240242
Substantially EquivalentAnhui Deepblue Medical Technology Co., Ltd.
FDA 510(k) clearance K240242 for HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold), Substantially Equivalent on 2024-10-11. Applicant: Anhui Deepblue Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Anhui Deepblue Medical Technology Co., Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hefei, CN
Recent devices under product code LCX
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More clearances from Anhui Deepblue Medical Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.