R D I N T

FDA Filings

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

FDA Owner/Operator Registration

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• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ROCHE MOLECULAR SYSTEMS, INC.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP160041 Supplement NumberS035 Date Received05/31/2022 Decision Date12/14/2022 Product Code PAB  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Resolution Bioscience, Inc.550 Kirkland Way, Suite 200kirkland, WA 98033 PMA NumberP210040 Date Received12/28/2021 Decision Date12/12/2022 Product Code PQP  Advisory Committee Clinical TrialsNCT03785249 Expedited Review Granted? No
• RxSight, Inc.100 Columbiaaliso Viejo, CA 92656 PMA NumberP160055 Supplement NumberS026 Date Received11/09/2022 Decision Date11/30/2022 Product Code PZK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP100020 Supplement NumberS054 Date Received10/21/2022 Decision Date11/14/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP140023 Supplement NumberS025 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100031 Supplement NumberS027 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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Related Finance Registrations

NCAGE Code	4KVQ1	R&D INTERNATIONAL
CAGE Code	4KVQ1	R&D INTERNATIONAL

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018092534488	Singapore,Singapore -> Los Angeles, California	T-SHIRTS SINGLETS TANK TOPS ETC KNIT ETC C MEN S KNIT 100 COTTO N INV.NO. NEZ RD 05 2018 L C NO 155130188 EXP NO. 134400994 18	192 CTN