Oncomine Dx Target Test

FDA Premarket Approval P160045 S023

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Manufacturing relocation of a reagent

DeviceOncomine Dx Target Test
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantLIFE TECHNOLOGIES CORPORATION
Date Received2020-10-01
Decision Date2020-11-11
PMAP160045
SupplementS023
Product CodePQP 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LIFE TECHNOLOGIES CORPORATION 5781 Van Allen Way carlsbad, CA 92008

Supplemental Filings

Supplement NumberDateSupplement Type
P160045Original Filing
S038 2022-08-05 Normal 180 Day Track No User Fee
S037 2022-06-14 Real-time Process
S036 2022-03-29 135 Review Track For 30-day Notice
S035 2022-03-08 Panel Track
S034 2021-12-23 Normal 180 Day Track No User Fee
S033
S032
S031
S030 2021-05-14 30-day Notice
S029
S028
S027
S026
S025
S024 2020-11-06 30-day Notice
S023 2020-10-01 30-day Notice
S022 2020-09-11 30-day Notice
S021
S020 2020-05-14 30-day Notice
S019
S018 2019-10-16 30-day Notice
S017
S016 2019-07-22 30-day Notice
S015 2019-04-23 30-day Notice
S014 2019-01-31 30-day Notice
S013 2019-01-25 30-day Notice
S012 2018-11-13 30-day Notice
S011 2018-10-19 30-day Notice
S010 2018-10-09 30-day Notice
S009
S008 2018-07-20 30-day Notice
S007
S006 2018-05-02 30-day Notice
S005 2018-03-22 Normal 180 Day Track No User Fee
S004
S003 2017-11-20 30-day Notice
S002 2017-11-08 30-day Notice
S001 2017-07-28 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10190302015103 P160045 000
10190302006156 P160045 000
10190302006095 P160045 000
10190302006064 P160045 000
10190302015646 P160045 000
10190302006071 P160045 000
10190302017756 P160045 000

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