PMA P060035S001
- Device
- ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S001
- Product code
- LOM
- Decision date
- 2009-06-23
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR MIGRATION OF THE ARCHITECT CORE-M ASSAY TO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.
Current openFDA PMA Record#
- Device
- ABBOTT ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2009-06-23
- Decision code
- APPR
- Date received
- 2009-01-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MIGRATION OF THE ARCHITECT CORE-M ASSAY TO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR.