|
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 | S004 |
Date Received | 08/29/2013 |
Decision Date | 01/24/2014 |
Product Code |
OWE |
Advisory Committee |
Pathology |
Clinical Trials | NCT00585195
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS. |