Approval for a change in the production site or the two antibodies used in the autodelia hafp kit to wallac oy, turk, finland, and for a change in the antigen source in the hafp standards of the autodelia hafp kit.
Device | AUTODELFIA HAFP KIT |
Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
Applicant | PerkinElmer, Inc. |
Date Received | 2008-09-17 |
Decision Date | 2009-04-08 |
PMA | P970037 |
Supplement | S002 |
Product Code | LOK |
Advisory Committee | Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | PerkinElmer, Inc. 940 Winter Street waltham, MA 02451 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P970037 | | Original Filing |
S012 |
2021-07-15 |
30-day Notice |
S011 |
2018-08-09 |
30-day Notice |
S010 |
2017-05-11 |
30-day Notice |
S009 |
2016-07-27 |
30-day Notice |
S008 |
2012-05-15 |
30-day Notice |
S007 |
2011-09-23 |
135 Review Track For 30-day Notice |
S006 |
2011-06-13 |
30-day Notice |
S005 |
2011-03-17 |
30-day Notice |
S004 |
2011-02-02 |
30-day Notice |
S003 |
2010-03-01 |
Normal 180 Day Track |
S002 |
2008-09-17 |
Normal 180 Day Track |
S001 |
2002-10-18 |
Special (immediate Track) |
NIH GUDID Devices