Last synced on 25 April 2025 at 11:05 pm

HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240242
510(k) Type
Traditional
Applicant
Anhui DEEPBLUE Medical Technology Co. LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/11/2024
Days to Decision
255 days
Submission Type
Summary

HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240242
510(k) Type
Traditional
Applicant
Anhui DEEPBLUE Medical Technology Co. LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/11/2024
Days to Decision
255 days
Submission Type
Summary