DIASORIN ETI-CORE-IGMK PLUS
FDA premarket approval P990044/S007 · decided 2005-06-22
Approval details
- PMA number
- P990044
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIASORIN ETI-CORE-IGMK PLUS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2005-06-03
- Decision date
- 2005-06-22
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
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