|
Device | ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street Walpole, MA 02032 |
PMA Number | P030029 |
Supplement Number | S001 |
Date Received | 03/14/2007 |
Decision Date | 08/02/2007 |
Withdrawal Date
|
05/24/2016 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
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 AN ADDITIONAL COMPONENT SUPPLIER. |