INTROL CF PANEL I CONTROL

Quality Control Material, Genetics, Dna

MAINE MOLECULAR QUALITY CONTROLS, INC.

The following data is part of a De Novo classification by Maine Molecular Quality Controls, Inc. with the FDA for Introl Cf Panel I Control.

Pre-market Notification Details

DeNovo IDDEN060007
Device Name:INTROL CF PANEL I CONTROL
ClassificationQuality Control Material, Genetics, Dna
Applicant MAINE MOLECULAR QUALITY CONTROLS, INC. 10 Southgate Road Scarborough,  ME  04074
ContactJoan Gordon
Product CodeNZB  
CFR Regulation Number866.5910 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK060070
Review Advisory BoardPathology
Classification AdvisoryMicrobiology
TypePost-NSE
Date Received2006-08-14
Decision Date2006-10-12
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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