PMA P840019S005
- Device
- TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY
- Applicant
- Hybritech, Inc.
- PMA number
- P840019
- Supplement
- S005
- Product code
- DHX
- Decision date
- 1986-11-05
- Classification
- System, Test, Carcinoembryonic Antigen
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Current openFDA PMA Record#
- Device
- TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY
- Applicant
- Hybritech, Inc.
- PMA number
- P840019
- Supplement
- S005
- Product code
- DHX
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Decision date
- 1986-11-05
- Decision code
- APPR
- Date received
- 1986-09-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other