FDA 510(k) Application Details - K172512

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K172512
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	ACRO Biotech, Inc. 9500 Seventh Street, Suite M Rancho Cucamonga, CA 91730 US Other 510(k) Applications for this Company
Contact	Joseph Fan Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2017
Decision Date	02/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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