|
Device | VYSIS ALK BREAK APART FISH PROBE KIT |
Generic Name | Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P110012 |
Supplement Number | S001 |
Date Received | 12/19/2011 |
Decision Date | 06/07/2012 |
Product Code |
OWE |
Advisory Committee |
Pathology |
Clinical Trials | NCT00585195
|
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR THE HUMAN PLACENTAL (HP) DNA COMPONENT FOR THE DEVICE, PER DESIGN VERIFICATION PROTOCOL MD17892. |