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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K152768
Device Name Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
Applicant
Assure Tech. Co., Ltd.
2nd. Floor, Bldg. 1, #10, Xiyuansan Rd.
Hangzhou,  CN 310030
Applicant Contact ERIC LIN
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact JOE SHIA
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/24/2015
Decision Date 02/24/2016
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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