Last synced on 25 April 2025 at 11:05 pm

HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233624
510(k) Type
Traditional
Applicant
Hangzhou Aichek Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/12/2024
Days to Decision
151 days
Submission Type
Summary

HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233624
510(k) Type
Traditional
Applicant
Hangzhou Aichek Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/12/2024
Days to Decision
151 days
Submission Type
Summary