FDA.reportPublic FDA data

MYRIAD GENETIC LABORATORIES, INC.

Matched from indexed company URL: Myriad Genetic Laboratories

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30306540683030654068MYRIAD GENETIC LABORATORIES, INC.1N2026-01-01322 N 2200 W Salt Lake City UT US 84116
30030347283003034728MYRIAD GENETIC LABORATORIES, INC.1N2020-04-25320 Wakara Way Salt Lake City UT US 84108

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3300291931400495P190014myChoice HRD CDxPJG2019-10-23
1791411841492350P140020BRACANALYSIS CDXPJG2014-12-19
3300291841492350P140020BRACANALYSIS CDXPJG2014-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PJG32019-10-23

PMA#

BRACAnalysis CDx®

2023-01-27

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 C...

BRACAnalysis CDx®

2022-11-16

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 Reas...

MyChoice CDx®

2022-11-14

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) Supplemen...

BRACAnalysis CDx®

2022-11-10

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 C...

BRACAnalysis CDx®

2022-03-11

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...