VYSIS ALK BREAK APART FISH PROBE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Premarket Approval P110012 S008

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

Replacement of the fermenters used in the fermentation processes.

DeviceVYSIS ALK BREAK APART FISH PROBE KIT
Classification NameFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
Generic NameFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
ApplicantABBOTT MOLECULAR, INC.
Date Received2014-07-24
Decision Date2014-08-14
PMAP110012
SupplementS008
Product CodeOWE
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P110012Original Filing
S021 2020-11-16 30-day Notice
S020 2019-12-23 Normal 180 Day Track
S019 2019-07-31 30-day Notice
S018 2019-04-10 30-day Notice
S017 2018-08-10 30-day Notice
S016 2018-06-15 30-day Notice
S015 2018-02-16 30-day Notice
S014 2017-11-08 30-day Notice
S013 2016-11-22 Real-time Process
S012 2016-09-12 30-day Notice
S011 2016-09-02 30-day Notice
S010 2016-06-01 30-day Notice
S009 2014-10-01 Normal 180 Day Track
S008 2014-07-24 30-day Notice
S007 2014-08-14 Real-time Process
S006 2014-06-16 30-day Notice
S005 2013-11-05 30-day Notice
S004 2013-08-29 Normal 180 Day Track No User Fee
S003 2013-03-20 30-day Notice
S002 2012-11-15 30-day Notice
S001 2011-12-19 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999025745 P110012 001
00884999000735 P110012 001
00884999042773 P110012 009
00884999042728 P110012 009
00884999038189 P110012 009

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