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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name menopause test system
De Novo Number DEN180004
Device Name picoAMH ELISA
Requester
ansh labs, llc
445 medical center blvd.
webster,  TX  77598
Contact ajay kumar
Regulation Number862.1093
Classification Product Code
QDH  
Date Received01/22/2018
Decision Date 10/24/2018
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Toxicology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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