Roche

FDA Filings

This page includes the latest FDA filings for Roche. 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
PMA P120019S032 ROCHE	cobas EGFR Mutation Test and cobas EGFR Mutation Test v2	2020-08-26
PMA P120019S030 ROCHE	cobas EGFR Mutation Test and cobas EGFR Mutation Test v2	2019-10-10
PMA P120019S029 ROCHE	cobas EGFR Mutation Test v2	2019-09-25
085749 ANDA ROCHE		0000-00-00 00:00:00
085303 ANDA ROCHE		0000-00-00 00:00:00
083639 ANDA ROCHE		0000-00-00 00:00:00
062510 ANDA ROCHE		0000-00-00 00:00:00
050565 NDA ROCHE		0000-00-00 00:00:00
021858 NDA ROCHE		0000-00-00 00:00:00
021511 NDA ROCHE		0000-00-00 00:00:00
021481 NDA ROCHE		0000-00-00 00:00:00
021246 NDA ROCHE		0000-00-00 00:00:00
021238 NDA ROCHE		0000-00-00 00:00:00
021087 NDA ROCHE		0000-00-00 00:00:00
020942 NDA ROCHE		0000-00-00 00:00:00
020813 NDA ROCHE		0000-00-00 00:00:00
020305 NDA ROCHE		0000-00-00 00:00:00
020239 NDA ROCHE		0000-00-00 00:00:00
020199 NDA ROCHE		0000-00-00 00:00:00
020137 NDA ROCHE		0000-00-00 00:00:00
019591 NDA ROCHE		0000-00-00 00:00:00
019369 NDA ROCHE		0000-00-00 00:00:00
019358 NDA ROCHE		0000-00-00 00:00:00
018557 NDA ROCHE		0000-00-00 00:00:00
018550 NDA ROCHE		0000-00-00 00:00:00
018179 NDA ROCHE		0000-00-00 00:00:00
017952 NDA ROCHE		0000-00-00 00:00:00
017589 NDA ROCHE		0000-00-00 00:00:00
017546 NDA ROCHE		0000-00-00 00:00:00
017533 NDA ROCHE		0000-00-00 00:00:00
016912 NDA ROCHE		0000-00-00 00:00:00
016149 NDA ROCHE		0000-00-00 00:00:00
016087 NDA ROCHE		0000-00-00 00:00:00
014740 NDA ROCHE		0000-00-00 00:00:00
013664 NDA ROCHE		0000-00-00 00:00:00
013294 NDA ROCHE		0000-00-00 00:00:00
013263 NDA ROCHE		0000-00-00 00:00:00
012715 NDA ROCHE		0000-00-00 00:00:00
012487 NDA ROCHE		0000-00-00 00:00:00
012486 NDA ROCHE		0000-00-00 00:00:00
011745 NDA ROCHE		0000-00-00 00:00:00
010423 NDA ROCHE		0000-00-00 00:00:00
010355 NDA ROCHE		0000-00-00 00:00:00
009660 NDA ROCHE		0000-00-00 00:00:00
009182 NDA ROCHE		0000-00-00 00:00:00
008983 NDA ROCHE		0000-00-00 00:00:00
008420 NDA ROCHE		0000-00-00 00:00:00
008414 NDA ROCHE		0000-00-00 00:00:00
007757 NDA ROCHE		0000-00-00 00:00:00
006917 NDA ROCHE		0000-00-00 00:00:00
006525 NDA ROCHE		0000-00-00 00:00:00
006071 NDA ROCHE		0000-00-00 00:00:00
003718 NDA ROCHE		0000-00-00 00:00:00

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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
• Roche Molecular System, Inc.4300 Hacienda Drivepleasanton, CA 94588 PMA NumberP200014 Supplement NumberS004 Date Received10/18/2022 Decision Date11/29/2022 Advisory Committee Pathology 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
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110037 Supplement NumberS057 Date Received10/21/2022 Decision Date11/14/2022 Product Code PAB  Advisory Committee Microbiology 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
• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100032 Supplement NumberS021 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	F2656	ROCHE
NCAGE Code	B0534	ROCHE
CAGE Code	B0534	ROCHE
CAGE Code	F2656	ROCHE