PMA P980041S035
- Device
- ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S035
- Product code
- LOK
- Decision date
- 2017-02-14
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Add another filling line for the filling, sealing, and labeling of calibrator bottles using the new Bottle/Vial Filler.
Current openFDA PMA Record#
- Device
- ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S035
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2017-02-14
- Decision code
- OK30
- Date received
- 2017-01-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add another filling line for the filling, sealing, and labeling of calibrator bottles using the new Bottle/Vial Filler.