PMA P030024S012

Device: ANTI-HBC REAGENT PACK AND CALIBRATOR
Applicant: Ortho-Clinical Diagnostics
PMA number: P030024
Supplement: S012
Product code: LOM
Decision date: 2010-07-16
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 ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.

Current openFDA PMA Record#

Device: ANTI-HBC REAGENT PACK AND CALIBRATOR
Applicant: Ortho-Clinical Diagnostics
PMA number: P030024
Supplement: S012
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2010-07-16
Decision code: APPR
Date received: 2009-12-01
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 ORTHO-CLINICAL DIAGNOSTICS, INC. IN SOUTH WALES, UNITED KINGDOM.