ARCHITECT CORE-M / Alinity i Anti-HBc IgM

Page Type

PMA Approval

PDF

* The FDA doesn't provide PDFs for all submissions.

Applicant

Abbott Laboratories

Trade Name

ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS

Generic Name

Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Decision Date

11/6/2007

Days to Decision

340 days

Decision Code

APPR

FDA Decision

Approval

FDA Browser

ARCHITECT CORE-M / Alinity i Anti-HBc IgM

Page Type: PMA Approval
PDF: PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: Abbott Laboratories
Trade Name: ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 11/6/2007
Days to Decision: 340 days
Decision Code: APPR
FDA Decision: Approval