FDA.reportPublic FDA data

PMA P110025

Device
Elecsys Anti-HBc IgM
Applicant
Roche Diagnostics Corp.
PMA number
P110025
Supplement
S023
Product code
LOM
Decision date
2019-04-24
Classification
Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Approval for a manufacturing site for the cobas e 411 Analyzer located at Hitachi High-Technologies Corp., 1892-1, Oazategama, Omuta, Fukuoka, 836-0004 Japan

Current openFDA PMA Record#

Device
Elecsys Anti-HBc IgM
Applicant
Roche Diagnostics Corp.
PMA number
P110025
Supplement
S023
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2019-04-24
Decision code
APPR
Date received
2018-10-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site for the cobas e 411 Analyzer located at Hitachi High-Technologies Corp., 1892-1, Oazategama, Omuta, Fukuoka, 836-0004 Japan