ABBOTT IMX HAVAB-M LIST 2263
FDA premarket approval P790019/S020 · decided 2005-10-06
Approval details
- PMA number
- P790019
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT IMX HAVAB-M LIST 2263
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2005-09-14
- Decision date
- 2005-10-06
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- Statement
- CHANGES IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, IMPLEMENTED TO IMPROVE MANUFACTURABILITY WITHOUT COMPROMISING PRODUCT PERFORMANCE.
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