|
Device | ABBOTT REALTIME HBV ASSAY |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P080026 |
Supplement Number | S014 |
Date Received | 03/26/2015 |
Decision Date | 04/23/2015 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO IMPLEMENT A NEW FULLY AUTOMATED SYSTEM FOR FILLING AND CAPPING COMPONENT BOTTLES. |