ABBOTT ANTI-DELTA EIA
FDA premarket approval P850062/S002 · decided 1997-02-26
Approval details
- PMA number
- P850062
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT ANTI-DELTA EIA
- Generic name
- HEPATITIS DELTA SEROLOGICAL REAGENTS
- Applicant
- Abbott Laboratories
- Date received
- 1997-01-21
- Decision date
- 1997-02-26
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LQI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE IN THE SPECIFICATIONS FOR THE CONJUGATE CONCENTRATE FROM A NEGATIVE CONTROL SAMPLE WITH A STANDARD RATION OF 0.90- 1.10, TO A NEGATIVE CONTROL MEAN O.D. OF 1.17 - 1.43
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