PMA P010051S005

Device: IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC
Applicant: Siemens Healthcare Diagnostics Products, Ltd.
PMA number: P010051
Supplement: S005
Product code: LOM
Decision date: 2008-12-16
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 LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD., WALES, UNITED KINGDOM.

Current openFDA PMA Record#

Device: IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC
Applicant: Siemens Healthcare Diagnostics Products, Ltd.
PMA number: P010051
Supplement: S005
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2008-12-16
Decision code: APPR
Date received: 2008-11-10
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 LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD., WALES, UNITED KINGDOM.