Myriad Genetic Laboratories I

FDA Filings

This page includes the latest FDA filings for Myriad Genetic Laboratories I. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

Similar & Related FDA Registered Companies

• Myriad Genetic Laboratories, Inc.
• MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS026 Date Received01/11/2023 Decision Date01/27/2023 Product Code PJG  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS025 Date Received10/18/2022 Decision Date11/16/2022 Product Code PJG  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Myriad Genetic Laboratories, Inc320 Wankara Waysalt Lake City, UT 84108 PMA NumberP190014 Supplement NumberS007 Date Received10/17/2022 Decision Date11/14/2022 Product Code PJG  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS024 Date Received10/14/2022 Decision Date11/10/2022 Product Code PJG  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS022 Date Received10/22/2021 Decision Date03/11/2022 Product Code PJG  Advisory Committee Pathology Clinical TrialsNCT02032823 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No