Cleared Traditional

MissLan? Digital Pregnancy Rapid Test

K222305 · Guangzhou Decheng Biotechnology Co., Ltd. · Chemistry
Nov 2022
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K222305 is an FDA 510(k) clearance for the MissLan? Digital Pregnancy Rapid Test, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 30, 2022, 121 days after receiving the submission on August 1, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K222305 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2022
Decision Date November 30, 2022
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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