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 TEST SYSTEM |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 |
PMA Number | P970037 |
Supplement Number | S008 |
Date Received | 05/15/2012 |
Decision Date | 06/14/2012 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement SECOND ALTERNATIVE TYPE OF TOPO (TRIOCTYLPHOSPHINE OXIDE) RAW MATERIAL TYPE USED IN THE MANUFACTURING OF THE ENHANCEMENT SOLUTION FOR THE DEVICE. |
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