PMA P110025S004
- Device
- ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110025
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2012-02-27
- 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
- CHANGE TO THE IN- PROCESS PARTICLE CONCENTRATION DETERMINATION METHOD FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.
Current openFDA PMA Record#
- Device
- ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110025
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-02-27
- Decision code
- OK30
- Date received
- 2012-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE IN- PROCESS PARTICLE CONCENTRATION DETERMINATION METHOD FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES.