PMA P820060S015
- Device
- ABBOTT AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S015
- Product code
- LOJ
- Decision date
- 2002-09-12
- Classification
- Immunology
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
Current openFDA PMA Record#
- Device
- ABBOTT AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S015
- Product code
- LOJ
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision date
- 2002-09-12
- Decision code
- APPR
- Date received
- 2002-09-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.