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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 clozapine test system
De Novo Number DEN190028
Device Name MyCare Psychiatry Clozapine Assay Kit
Requester
saladax biomedical, inc.
116 research dr.
bethlehem,  PA  18015
Contact sue werner
Regulation Number862.3245
Classification Product Code
QKT  
Date Received05/24/2019
Decision Date 04/16/2020
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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