PMA P050042S006

Device: ABBOTT ARCHITECT ANTI-HCV
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S006
Product code: MZO
Decision date: 2011-01-04
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED IN DELKENHEIM, GERMANY FOR THE MANUFACTURE OF ARCHITECT ANTI-HCV REAGENT KIT, ARCHITECT ANTI-HCV CALIBRATOR, AND ARCHITECT ANTI-HCV CONTROLS.

Current openFDA PMA Record#

Device: ABBOTT ARCHITECT ANTI-HCV
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S006
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2011-01-04
Decision code: APPR
Date received: 2010-08-02
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 IN DELKENHEIM, GERMANY FOR THE MANUFACTURE OF ARCHITECT ANTI-HCV REAGENT KIT, ARCHITECT ANTI-HCV CALIBRATOR, AND ARCHITECT ANTI-HCV CONTROLS.