Device Listing 1513741180

Listing Summary#

Listing key
1513741180
Premarket submission
P210003
Device
ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
Applicant
Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Date Received02/08/2021 Decision Date08/10/2022 Product Code LOM  Advisory Committee Microbiology Expedited Review Granted? No
Product code
LOMĀ 
Decision date
2022-08-10