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 ID: DEN060001
• Device Name: PHICAL TEST
• Classification: Calprotectin, Fecal
• Applicant: GENOVA DIAGNOSTICS 63 Zillicoa St. Asheville, NC 28801 -1074
• Contact: Patrick Hanaway
• Product Code: NXO
• CFR Regulation Number: 866.5180 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: K050007
• Review Advisory Board: Immunology
• Classification Advisory: Immunology
• Type: Post-NSE
• Date Received: 2006-03-23
• Decision Date: 2006-04-26
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08028169204215	DEN060001	000