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Elecsys Anti-HBc II

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: ROCHE DIAGNOSTICS CORP.
Trade Name: ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 6/27/2011
Days to Decision: 332 days
Decision Code: APPR
FDA Decision: Approval

FDA Browser

Elecsys Anti-HBc II

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: ROCHE DIAGNOSTICS CORP.
Trade Name: ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 6/27/2011
Days to Decision: 332 days
Decision Code: APPR
FDA Decision: Approval