D F I Co L T D

FDA Filings

This page includes the latest FDA filings for D F I Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K052525 D.F.I. CO LTD	CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS	2006-03-29

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• Datex-Ohmeda, Inc., A General Electric Companyp.o. Box 7550madison, WI 53707-7550 PMA NumberP210018 Date Received05/03/2021 Decision Date03/17/2022 Product Code QSF  Advisory Committee Anesthesiology Clinical TrialsNCT02972892 Expedited Review Granted? No
• DEPUY, A JOHNSON & JOHNSON CO.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS003 Date Received08/10/1999 Decision Date12/22/1999 Reclassified Date 05/30/2002 Product Code KWZ  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY, A JOHNSON & JOHNSON CO.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS002 Date Received07/30/1999 Decision Date12/07/1999 Reclassified Date 05/30/2002 Product Code KWZ  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• DEPUY, A JOHNSON & JOHNSON CO.p.o. Box 988700 Orthopaedic Drivewarsaw, IN 46581-0988 PMA NumberP960054 Supplement NumberS004 Date Received10/06/1999 Decision Date11/10/1999 Reclassified Date 05/30/2002 Product Code KWZ  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo
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