|
Device | DAKOCYTOMATION HER2 FISH PHARMDX KIT |
Generic Name | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM |
Applicant | Agilent Technologies Singapore (International) Pte Ltd. No. 1 Yishun Avenue 7 Singapore 76892 |
PMA Number | P040005 |
Supplement Number | S013 |
Date Received | 03/16/2016 |
Decision Date | 04/12/2016 |
Product Code |
MVD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Changes to the DNA propagation and purification processes. |