PMA P790025
- Device
- ABBOTT HBE (RDNA) EIA
- Applicant
- Abbott Laboratories
- PMA number
- P790025
- Supplement
- S006
- Product code
- LOM
- Decision date
- 2003-01-17
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGES TO MANUFACTURING PROCESS, TEST METHOD ADDITIONS, AND SPECIFICATION CHANGES.
Current openFDA PMA Record
- Device
- ABBOTT HBE (RDNA) EIA
- Applicant
- Abbott Laboratories
- PMA number
- P790025
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2003-01-17
- Decision code
- OK30
- Date received
- 2002-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO MANUFACTURING PROCESS, TEST METHOD ADDITIONS, AND SPECIFICATION CHANGES.