Oncomine Dx Target Test

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Premarket Approval P160045 S018

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

A new pcr tube is provided with the kit

DeviceOncomine Dx Target Test
Classification NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantLIFE TECHNOLOGIES CORPORATION
Date Received2019-10-16
Decision Date2019-11-13
PMAP160045
SupplementS018
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
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

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