BIO-RAD MONOLISA ANTI-HBC IGM EIA
FDA premarket approval P060034/S006 · decided 2012-11-13
Approval details
- PMA number
- P060034
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIO-RAD MONOLISA ANTI-HBC IGM EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 2012-10-19
- Decision date
- 2012-11-13
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- CHANGE TO AUTOMATE THE FILLING AND CAPPING PROCESS FOR COMPONENTS IN THE DEVICES.
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