PHICAL TEST

Calprotectin, Fecal

GENOVA DIAGNOSTICS

The following data is part of a De Novo classification by Genova Diagnostics with the FDA for Phical Test.

Pre-market Notification Details

DeNovo IDDEN060001
Device Name:PHICAL TEST
ClassificationCalprotectin, Fecal
Applicant GENOVA DIAGNOSTICS 63 Zillicoa St. Asheville,  NC  28801 -1074
ContactPatrick Hanaway
Product CodeNXO  
CFR Regulation Number866.5180 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK050007
Review Advisory BoardImmunology
Classification AdvisoryImmunology
TypePost-NSE
Date Received2006-03-23
Decision Date2006-04-26
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08028169204215 DEN060001 000
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