PMA P050042S001

Device: ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S001
Product code: MZO
Decision date: 2006-08-14
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: APPROVAL FOR THE ADDITION OF A TEST METHOD TO DETECT CHANGES BETWEEN THE BULK AND THE MASTER LOT (CUSTOMER RELEASE) TESTING STAGES.

Current openFDA PMA Record#

Device: ARCHITECT ANTI-HCV REAGENT KITS, ARCHITECT ANTI-HCV CALIBRATORS, AND ARCHITECT ANTI-HCV CONTROLS
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S001
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2006-08-14
Decision code: APPR
Date received: 2006-06-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF A TEST METHOD TO DETECT CHANGES BETWEEN THE BULK AND THE MASTER LOT (CUSTOMER RELEASE) TESTING STAGES.