PMA P060034S006
- Device
- BIO-RAD MONOLISA ANTI-HBC IGM EIA
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P060034
- Supplement
- S006
- Product code
- LOM
- Decision date
- 2012-11-13
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- CHANGE TO AUTOMATE THE FILLING AND CAPPING PROCESS FOR COMPONENTS IN THE DEVICES.
Current openFDA PMA Record#
- Device
- BIO-RAD MONOLISA ANTI-HBC IGM EIA
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P060034
- Supplement
- S006
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-11-13
- Decision code
- OK30
- Date received
- 2012-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO AUTOMATE THE FILLING AND CAPPING PROCESS FOR COMPONENTS IN THE DEVICES.