PMA P830066S012
- Device
- Abbott Cea-ria Monoclonal
- Applicant
- Abbott Laboratories
- PMA number
- P830066
- Supplement
- S012
- Decision date
- 1995-07-12
Current openFDA PMA Record
- Device
- ABBOTT CEA-RIA MONOCLONAL
- Applicant
- Abbott Laboratories
- PMA number
- P830066
- Supplement
- S012
- Product code
- DHX
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Decision date
- 1995-07-12
- Decision code
- APPR
- Date received
- 1995-06-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE PACKAGE LABELING TO DECREASE THE "HOOK" VALUE FROM 100,00 TO 60,000 NG CEA/ML