PMA P840019S010
- Device
- STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY
- Applicant
- Hybritech, Inc.
- PMA number
- P840019
- Supplement
- S010
- Product code
- DHX
- Decision date
- 1994-03-17
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Current openFDA PMA Record#
- Device
- STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY
- Applicant
- Hybritech, Inc.
- PMA number
- P840019
- Supplement
- S010
- Product code
- DHX
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Decision date
- 1994-03-17
- Decision code
- APPR
- Date received
- 1991-09-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material