|
Device | VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P030024 |
Supplement Number | S009 |
Date Received | 11/13/2008 |
Decision Date | 01/14/2009 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHO-CLINICAL DIAGNOSTICS IN PENCOED BRIDGEND, UNITED KINGDOM. |