PMA P820060S030

Device: AXSYM AFP (LN 7A48)
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S030
Product code: LOK
Decision date: 2011-12-22
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
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 AFP (LN 7A48)
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S030
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
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.