ETI-AB-EBK PLUS KIT
FDA premarket approval P990041/S013 · decided 2011-11-15
Approval details
- PMA number
- P990041
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETI-AB-EBK PLUS KIT
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2011-10-18
- Decision date
- 2011-11-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- SECOND VENDOR OF CHROMOGEN/ SUBSTRATE BULK SOLUTION.
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