PMA P980041S037
- Device
- Access AFP Reagents on the Access Immunoassy Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S037
- Product code
- LOK
- Decision date
- 2017-07-07
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.
Current openFDA PMA Record#
- Device
- Access AFP Reagents on the Access Immunoassy Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S037
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2017-07-07
- Decision code
- OK30
- Date received
- 2017-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.