MyCare Psychiatry Clozapine Assay Kit

Clozapine Test System

Saladax Biomedical Inc

The following data is part of a De Novo classification by Saladax Biomedical Inc with the FDA for Mycare Psychiatry Clozapine Assay Kit.

Pre-market Notification Details

DeNovo IDDEN190028
Device Name:MyCare Psychiatry Clozapine Assay Kit
ClassificationClozapine Test System
Applicant Saladax Biomedical Inc 116 Research Drive Bethlehem,  PA  18015
ContactSue Werner
Product CodeQKT  
CFR Regulation Number862.3245 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardToxicology
Classification AdvisoryClinical Chemistry
Date Received2019-05-24
Decision Date2020-04-16
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
00894354002236 DEN190028 000

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