PMA P850062
- Device
- ABBOTT ANTI-DELTA (EIA) ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P850062
- Supplement
- S002
- Product code
- LQI
- Decision date
- 2002-09-05
- Generic name
- HEPATITIS DELTA SEROLOGICAL REAGENTS
- Approval order statement
- APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.
Current openFDA PMA Record
- Device
- ABBOTT ANTI-DELTA (EIA) ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P850062
- Supplement
- S003
- Product code
- LQI
- Generic name
- HEPATITIS DELTA SEROLOGICAL REAGENTS
- Decision date
- 2002-09-05
- Decision code
- APPR
- Date received
- 2001-10-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.