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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 K132085
Device Name ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
Applicant
Co-Innovation Biotech Co., Ltd.
# 13 Yanyuan Rd.. Tianhe District
Guangzhou, Guangdong,  CN 510507
Applicant Contact HONG FENG
Correspondent
Co-Innovation Biotech Co., Ltd.
# 13 Yanyuan Rd.. Tianhe District
Guangzhou, Guangdong,  CN 510507
Correspondent Contact HONG FENG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received07/05/2013
Decision Date 11/12/2013
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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