PMA P120008S007
- Device
- ARCHITECT AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S007
- Product code
- LOK
- Decision date
- 2014-12-11
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
Current openFDA PMA Record#
- Device
- ARCHITECT AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S007
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2014-12-11
- Decision code
- OK30
- Date received
- 2014-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.