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Companies starting with “ROCHE MOLECULAR SYSTEMS”

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• ROCHE MOLECULAR SYSTEMS, INC.
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP050028 Supplement NumberS086 Date Received10/21/2022 Decision Date11/14/2022 Product Code MKT  Advisory Committee Microbiology 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 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
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110020 Supplement NumberS037 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
• 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 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