Myriad Genetic Laboratories Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3003034728
• FEI Number: 3003034728
• Name: MYRIAD GENETIC LABORATORIES, INC.
• Owner & Operator: Myriad Genetic Laboratories, Inc.
• Contact Address: 320 Wakara Way ; Salt Lake City UT 84108 US
• Official Correspondent:
  • Jolette Franco
  • x-801-5843600-1188
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 320 Wakara Way ; Salt Lake City, UT 84108 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P190014S006 Myriad Genetic Laboratories, Inc	myChoice CDx	2022-02-10
PMA P190014S005 Myriad Genetic Laboratories, Inc	myChoice HRD CDx	2021-06-24
PMA P190014S004 Myriad Genetic Laboratories, Inc	myChoice CDx	2021-01-27
PMA P190014S003 Myriad Genetic Laboratories, Inc	myChoice CDx	2020-05-08
PMA P190014S001 Myriad Genetic Laboratories, Inc	myChoice CDx	2020-04-29
PMA P190014S002 Myriad Genetic Laboratories, Inc	myChoice CDx	2020-03-23
PMA P190014 Myriad Genetic Laboratories, Inc	myChoice HRD CDx	2019-10-23
PMN P140020 | PJG MYRIAD GENETIC LABORATORIES, INC.	BRACAnalysis CDx	2015-01-12

Similar & Related FDA Registered Companies

• 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

Related Finance Registrations

NCAGE Code	1UFV3	MYRIAD GENETIC LABORATORIES INC
CAGE Code	1UFV3	MYRIAD GENETIC LABORATORIES INC
S.A.M. Registration	1UFV3 [962592424]	MYRIAD GENETIC LABORATORIES INC