PMA P160038S010

Device
Praxis Extended RAS Panel
Applicant
Illumina, Inc.
PMA number
P160038
Supplement
S010
Product code
PQP
Decision date
2019-03-25
Classification
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement
Update an enzymes purification processing steps.

Current openFDA PMA Record#

Device
Praxis Extended RAS Panel
Applicant
Illumina, Inc.
PMA number
P160038
Supplement
S010
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2019-03-25
Decision code
OK30
Date received
2019-03-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update an enzymes purification processing steps.