← DeviceClear
HomeDevice Clearances

HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step — Hangzhou Aichek Medical Technology Co.

HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step — Hangzhou Aichek Medical Technology Co. is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step; Applicant

Device nameHCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step
ApplicantHangzhou Aichek Medical Technology Co., Ltd.
Clearance track510(k)
Submission numberK233624
DecisionSubstantially Equivalent
Decision date2024-04-12
Date received2023-11-13
Product codeLCX
Device class2
Medical specialtyClinical Chemistry
Applicant locationCN
SourceopenFDA device

🔍 Search all device clearances →