PMA P970027S017

Device: AXSYM ANTI-HCV (LN 5C36)
Applicant: Abbott Laboratories
PMA number: P970027
Supplement: S017
Product code: MZO
Decision date: 2011-12-22
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.

Current openFDA PMA Record

Device: AXSYM ANTI-HCV (LN 5C36)
Applicant: Abbott Laboratories
PMA number: P970027
Supplement: S017
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2011-12-22
Decision code: APPR
Date received: 2011-11-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.