Approval for a change of the dispensing line used in the manufacturing of the calibrators for the autodelfia and delfia xpress hafp kits and the buffer solution for the delfia xpress hafp kit.
Device | AUOTDELFIA 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 | 2011-09-23 |
Decision Date | 2012-04-27 |
PMA | P970037 |
Supplement | S007 |
Product Code | LOK |
Advisory Committee | Immunology |
Supplement Type | 135 Review Track For 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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