Note: 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. |
|
Device | AUTODELFIA HAFP KIT |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 |
PMA Number | P970037 |
Supplement Number | S002 |
Date Received | 09/17/2008 |
Decision Date | 04/08/2009 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
|
|