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ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ABBOTT LABORATORIES INC
Trade Name
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
Generic Name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date
6/7/2006
Days to Decision
196 days
Decision Code
APPR
FDA Decision
Approval

ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ABBOTT LABORATORIES INC
Trade Name
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
Generic Name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date
6/7/2006
Days to Decision
196 days
Decision Code
APPR
FDA Decision
Approval