Myriad Genetic Laboratories

FDA Filings

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

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P140020S021 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2021-07-02
PMA P140020S020 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2020-05-19
PMA P140020S019 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2019-12-27
PMA P140020S014 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2019-03-06
PMA P140020S018 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2018-12-19
PMA P140020S017 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2018-10-25
PMA P140020S016 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2018-10-16
PMA P140020S015 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx device	2018-10-16
PMA P140020S012 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2018-01-12
PMA P140020S013 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2017-10-26
PMA P140020S009 MYRIAD GENETIC LABORATORIES	BRACAnalysis CDx	2017-03-27
PMA P140020S008 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX	2017-01-30
PMA P140020S002 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX	2016-07-26
PMA P140020S007 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDx	2016-06-17
PMA P140020S006 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX	2016-06-17
PMA P140020S001 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX	2016-04-29
PMA P140020S005 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX DEVICE	2016-02-18
PMA P140020S004 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX	2015-12-22
PMA P140020S003 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX	2015-11-18
PMA P140020 MYRIAD GENETIC LABORATORIES	BRACANALYSIS CDX	2014-12-19

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

Related Finance Registrations