PMA P990012S016

Device: ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST
Applicant: Roche Diagnostics Corp.
PMA number: P990012
Supplement: S016
Product code: LOM
Decision date: 2013-05-14
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 CHANGE TO THE SPECIFICATIONS FOR THE NEGATIVE HUMAN SERUM INCOMING MATERIAL.

Current openFDA PMA Record#

Device: ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST
Applicant: Roche Diagnostics Corp.
PMA number: P990012
Supplement: S016
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2013-05-14
Decision code: APPR
Date received: 2012-10-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE SPECIFICATIONS FOR THE NEGATIVE HUMAN SERUM INCOMING MATERIAL.