|
Device | IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 BENEDICT AVE. TARRYTOWN, NY 10591 |
PMA Number | P010007 |
Supplement Number | S007 |
Date Received | 08/16/2011 |
Decision Date | 09/12/2011 |
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 PERMANENT IMPLEMENTATION OF THE INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING. |