Device Listing 1748108776

Listing Summary#

Listing key
1748108776
Premarket submission
P210019
Device
ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
Applicant
Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Date Received05/11/2021 Decision Date07/27/2022 Product Code LOM  Advisory Committee Microbiology Expedited Review Granted? No
Product code
LOMĀ 
Decision date
2022-07-27