|
Device | INFORM HER2 DUAL ISH DNA PROBE COCKTAIL |
Generic Name | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P100027 |
Supplement Number | S019 |
Date Received | 06/16/2014 |
Decision Date | 02/19/2015 |
Withdrawal Date
|
05/07/2024 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS. |