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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 K180771
Device Name Acro HCG Pregnancy Rapid Test
Applicant
Acro Biotech, Inc.
9500 Seventh St., Suite M
Rancho Cucamonga,  CA  91730
Applicant Contact Joseph Fan
Correspondent
Ivdd Regulatory Consultant
29222 Rancho Viejo Rd.
Suite 218
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number862.1155
Classification Product Code
LCX  
Date Received03/23/2018
Decision Date 05/18/2018
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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