Cleared Traditional

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

K240242 · Anhui Deepblue Medical Technology Co., Ltd. · Chemistry

Oct 2024

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K240242 is an FDA 510(k) clearance for the HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold), a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Anhui Deepblue Medical Technology Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on October 11, 2024, 255 days after receiving the submission on January 30, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K240242 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2024
Decision Date	October 11, 2024
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF