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 | VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES |
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 | S003 |
Date Received | 03/20/2013 |
Decision Date | 04/17/2013 |
Product Code |
OWE |
Advisory Committee |
Pathology |
Clinical Trials | NCT00585195
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Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement THREE MANUFACTURING CHANGES, INCLUDING THE ADDITION OF A WORKING CELL BANK, IMPLEMENTATION OF A PRE-FERMENTATION OPTICAL DENSITY READING, AND MODIFICATION TO PROPAGATING THE CELL LINE USED TO MAKE NEGATIVE CONTROL SLIDES. |
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