PMA P820060S029
- Device
- Abbott Axsym Afp
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S029
- Decision date
- 2011-05-12
Current openFDA PMA Record
- Device
- ABBOTT AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S029
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2011-05-12
- Decision code
- OK30
- Date received
- 2011-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE SPECIFICATIONS FOR IN- PROCESS TESTING AND CUSTOMER RELEASE TESTING FOR AXSYM AFP AS A RESULT OF AN INTERNAL REVIEW OF THE PRODUCT RELATIVE TO UPDATED SPECIFICATION SETTING PROCEDURES.