PMA P850009S004
- Device
- CA 125 ANTIBODY RIA
- Applicant
- Centocor, Inc.
- PMA number
- P850009
- Supplement
- S004
- Product code
- LTK
- Decision date
- 1991-03-28
- Generic name
- TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
Current openFDA PMA Record#
- Device
- CA 125 ANTIBODY RIA
- Applicant
- Centocor, Inc.
- PMA number
- P850009
- Supplement
- S004
- Product code
- LTK
- Generic name
- TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
- Decision date
- 1991-03-28
- Decision code
- APPR
- Date received
- 1990-11-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename