ABBOTT ANTI-DELTA (EIA) ASSAY
FDA premarket approval P850062/S003 · decided 2002-09-05
Approval details
- PMA number
- P850062
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT ANTI-DELTA (EIA) ASSAY
- Generic name
- HEPATITIS DELTA SEROLOGICAL REAGENTS
- Applicant
- Abbott Laboratories
- Date received
- 2001-10-03
- Decision date
- 2002-09-05
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- LQI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.
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