PMA P140020S004

Device
BRACANALYSIS CDX
Applicant
Myriad Genetic Laboratories
PMA number
P140020
Supplement
S004
Product code
PJG
Decision date
2015-12-22
Classification
Cancer-related Germline Gene Mutation Detection System
Generic name
Cancer-related germline gene mutation detection system
Approval order statement
CHANGES TO THE LABORATORY SPACE LAYOUT.

Current openFDA PMA Record#

Device
BRACANALYSIS CDX
Applicant
Myriad Genetic Laboratories
PMA number
P140020
Supplement
S004
Product code
PJG
Generic name
Cancer-related germline gene mutation detection system
Decision date
2015-12-22
Decision code
OK30
Date received
2015-11-25
Supplement type
30-Day Notice
Approval order statement
CHANGES TO THE LABORATORY SPACE LAYOUT.