PMA P120008S004
- Device
- ARCHITECT AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S004
- Product code
- LOK
- Decision date
- 2013-11-26
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
Current openFDA PMA Record#
- Device
- ARCHITECT AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S004
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2013-11-26
- Decision code
- OK30
- Date received
- 2013-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.