PMA P920021
- Device
- OPUS(R) CEA TEST SYSTEM
- Applicant
- Behring Diagnostics, Inc.
- PMA number
- P920021
- Supplement
- S001
- Product code
- DHX
- Decision date
- 1996-02-23
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Approval order statement
- APPROVAL TO ADD THE CEA TEST SYSTEM TO THE OPUS PLUS AND OPUS MAGNUM ANALYZERS. THE SAME TEST SYSTEM IS USED ON ALL THREE INSTRUMENTS
Current openFDA PMA Record#
- Device
- OPUS(R) CEA TEST SYSTEM
- Applicant
- Behring Diagnostics, Inc.
- PMA number
- P920021
- Supplement
- S001
- Product code
- DHX
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Decision date
- 1996-02-23
- Decision code
- APPR
- Date received
- 1995-07-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO ADD THE CEA TEST SYSTEM TO THE OPUS PLUS AND OPUS MAGNUM ANALYZERS. THE SAME TEST SYSTEM IS USED ON ALL THREE INSTRUMENTS