Cleared Traditional

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream

K200133 · Safecare Biotech (Hangzhou) Co., Ltd. · Chemistry
Aug 2020
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K200133 is an FDA 510(k) clearance for the hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 13, 2020, 205 days after receiving the submission on January 21, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K200133 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2020
Decision Date August 13, 2020
Days to Decision 205 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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