|
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 | S003 |
Date Received | 04/02/2012 |
Decision Date | 09/26/2012 |
Product Code |
MKT |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE FROM A MANUAL ASSEMBLY SYSTEM TO AN AUTOMATED PROCESS FOR KIT PACKAGING. |