Cleared Traditional

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Chemistry

Jan 2025

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K242135 is an FDA 510(k) clearance for the Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Nanjing Synthgene Medical Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on January 31, 2025, 193 days after receiving the submission on July 22, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K242135 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2024
Decision Date	January 31, 2025
Days to Decision	193 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF