PMA P800025
- Device
- QUANTITOPE 125I AFP KIT AND CONTROL SERUM
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P800025
- Supplement
- S005
- Product code
- LOK
- Decision date
- 1996-10-02
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- REPLACEMENT OF THE CURRENT RADIOLABELED AFP WITH A NEW AFP ANTIGEN
Current openFDA PMA Record#
- Device
- QUANTITOPE 125I AFP KIT AND CONTROL SERUM
- Applicant
- Bio-Rad Laboratories, Inc.
- PMA number
- P800025
- Supplement
- S005
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 1996-10-02
- Decision code
- APPR
- Date received
- 1995-12-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- REPLACEMENT OF THE CURRENT RADIOLABELED AFP WITH A NEW AFP ANTIGEN