PMA P850062S002
- Device
- Abbott Anti-delta Eia
- Applicant
- Abbott Laboratories
- PMA number
- P850062
- Supplement
- S002
- Decision date
- 1997-02-26
Current openFDA PMA Record
- Device
- ABBOTT ANTI-DELTA EIA
- Applicant
- Abbott Laboratories
- PMA number
- P850062
- Supplement
- S002
- Product code
- LQI
- Generic name
- HEPATITIS DELTA SEROLOGICAL REAGENTS
- Decision date
- 1997-02-26
- Decision code
- APPR
- Date received
- 1997-01-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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