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ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ROCHE DIAGNOSTICS OPERATIONS INC
Trade Name
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
Generic Name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date
6/11/2015
Days to Decision
253 days
Decision Code
APPR
FDA Decision
Approval

ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ROCHE DIAGNOSTICS OPERATIONS INC
Trade Name
ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
Generic Name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date
6/11/2015
Days to Decision
253 days
Decision Code
APPR
FDA Decision
Approval