PMA P060035S013
- Device
- ARCHITECT CORE-M
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2011-12-21
- 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 A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.
Current openFDA PMA Record#
- Device
- ARCHITECT CORE-M
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-12-21
- Decision code
- APPR
- Date received
- 2011-11-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN THE DEVICE.