PMA P160019S009

Device: Elecsys HBsAg II
Applicant: Roche Diagnostics, Inc.
PMA number: P160019
Supplement: S009
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 HBsAg II
Applicant: Roche Diagnostics, Inc.
PMA number: P160019
Supplement: S009
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