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
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
10190302006064 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006156 P160045 000
10190302006095 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006156 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302015103 P160045 000
10190302006095 P160045 000
10190302006064 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302006064 P160045 000
10190302006095 P160045 000
10190302006156 P160045 000
10190302015103 P160045 000

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