PMA P840027S002
- Device
- CEA-ROCHE(R) EIA
- Applicant
- Roche Diagnostics GmbH
- PMA number
- P840027
- Supplement
- S002
- Product code
- DHX
- Decision date
- 1987-02-19
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Current openFDA PMA Record#
- Device
- CEA-ROCHE(R) EIA
- Applicant
- Roche Diagnostics GmbH
- PMA number
- P840027
- Supplement
- S002
- Product code
- DHX
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Decision date
- 1987-02-19
- Decision code
- APPR
- Date received
- 1986-08-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename