Vendors relocation of a manufacturing site for production of reagents contained in kit components.
Device | Path Vysion HER-2 DNA Probe Kit |
Classification Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
Generic Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
Applicant | ABBOTT MOLECULAR, INC. |
Date Received | 2017-11-08 |
Decision Date | 2017-12-06 |
PMA | P980024 |
Supplement | S016 |
Product Code | MVD |
Advisory Committee | Pathology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P980024 | | Original Filing |
S022 |
2022-02-18 |
30-day Notice |
S021 |
2020-11-16 |
30-day Notice |
S020 |
2019-04-10 |
30-day Notice |
S019 |
2018-08-10 |
30-day Notice |
S018 |
2018-06-15 |
30-day Notice |
S017 |
2018-02-16 |
30-day Notice |
S016 |
2017-11-08 |
30-day Notice |
S015 |
2016-09-02 |
30-day Notice |
S014 |
2016-06-01 |
30-day Notice |
S013 |
2014-06-16 |
30-day Notice |
S012 |
2013-11-25 |
30-day Notice |
S011 |
2013-11-05 |
30-day Notice |
S010 |
2013-01-16 |
30-day Notice |
S009 |
2012-11-15 |
30-day Notice |
S008 |
2012-06-21 |
Special (immediate Track) |
S007 |
2012-06-14 |
135 Review Track For 30-day Notice |
S006 |
2011-10-17 |
135 Review Track For 30-day Notice |
S005 |
2011-02-22 |
135 Review Track For 30-day Notice |
S004 |
2010-12-22 |
30-day Notice |
S003 |
2009-01-15 |
30-day Notice |
S002 |
2005-06-20 |
Normal 180 Day Track No User Fee |
S001 |
2001-03-30 |
Panel Track |
NIH GUDID Devices