Control-IQ Technology

Interoperable Automated Glycemic Controller

Tandem Diabetes Care, Inc.

The following data is part of a De Novo classification by Tandem Diabetes Care, Inc. with the FDA for Control-iq Technology.

Pre-market Notification Details

DeNovo IDDEN190034
Device Name:Control-IQ Technology
ClassificationInteroperable Automated Glycemic Controller
Applicant Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego,  CA  92121
ContactMichael Sarrasin
Product CodeQJI  
CFR Regulation Number862.1356 [🔎]
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 BoardClinical Chemistry
Classification AdvisoryClinical Chemistry
TypeDirect
Date Received2019-07-15
Decision Date2019-12-13
Reclassification Order:Reclassification Order

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