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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K200133
Device Name hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
Applicant
Safecare Biotech (Hangzhou) Co., Ltd.
18 Haishu Rd., Yuhang District
Hangzhou,  CN
Applicant Contact Selina Zhang
Correspondent
Safecare Biotech (Hangzhou) Co., Ltd.
18 Haishu Rd., Yuhang District
Hangzhou,  CN
Correspondent Contact Selina Zhang
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/21/2020
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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