ETI-AB-COREK PLUS
FDA premarket approval P990045/S008 · decided 2005-08-29
Approval details
- PMA number
- P990045
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETI-AB-COREK PLUS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2005-08-03
- Decision date
- 2005-08-29
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- CHANGE IN DETERMINATION OF SPECIFIC ATTRIBUTES OF QUALITY CONTROL FOR A RAW REAGENT.
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