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 ID: DEN190028
• Device Name: MyCare Psychiatry Clozapine Assay Kit
• Classification: Clozapine Test System
• Applicant: Saladax Biomedical Inc 116 Research Drive Bethlehem, PA 18015
• Contact: Sue Werner
• Product Code: QKT
• CFR Regulation Number: 862.3245 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Toxicology
• Classification Advisory: Clinical Chemistry
• Type: Direct
• Date Received: 2019-05-24
• Decision Date: 2020-04-16
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00894354002236	DEN190028	000
00894354002397	DEN190028	000