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. |
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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 | S005 |
Date Received | 03/17/2011 |
Decision Date | 04/08/2011 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN A RAW MATERIAL USED IN THE MANUFACTURE OF THE ENHANCEMENT SOLUTION AUXILIARY REAGENT USED WITH THE AUTODELFIA HAFP KIT. |
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