PMA P980041S004
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S004
- Product code
- LOK
- Decision date
- 2004-01-20
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BECKMAN COULTER, INC., CHASKA, MINNESOTA.
Current openFDA PMA Record#
- Device
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S004
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2004-01-20
- Decision code
- APPR
- Date received
- 2003-12-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BECKMAN COULTER, INC., CHASKA, MINNESOTA.