HAVAB-M (R) EIA
FDA premarket approval P790019/S012 · decided 2002-09-05
Approval details
- PMA number
- P790019
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HAVAB-M (R) EIA
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Abbott Laboratories
- Date received
- 2001-10-03
- Decision date
- 2002-09-05
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park North, IL
- Statement
- APPROVAL TO ADD ADDITIONAL TESTING TO THE HAVAB-M EIA MASTERLOT TO PROVIDE A QUALITY CHECK OF THE FINAL PACKAGED KIT.
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