PMA P820060S019
- Device
- ABBOTT AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S019
- Product code
- LOJ
- Decision date
- 2004-02-02
- Classification
- Immunology
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Approval order statement
- APPROVAL FOR A CHANGE IN PROTOCOL FOR THE AUTOMATED DILUTION PROTOCOL IN ABBOTT AXSYM SOFTWARE VERSION 3.60 AND VERSION 4.01.
Current openFDA PMA Record#
- Device
- ABBOTT AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S019
- Product code
- LOJ
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision date
- 2004-02-02
- Decision code
- APPR
- Date received
- 2003-08-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN PROTOCOL FOR THE AUTOMATED DILUTION PROTOCOL IN ABBOTT AXSYM SOFTWARE VERSION 3.60 AND VERSION 4.01.