OPUS(R) CEA TEST SYSTEM
FDA premarket approval P920021/S001 · decided 1996-02-23
Approval details
- PMA number
- P920021
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPUS(R) CEA TEST SYSTEM
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Behring Diagnostics, Inc.
- Date received
- 1995-07-03
- Decision date
- 1996-02-23
- Days to decision
- 235 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Westwood, MA
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS HLH CONTROLS (K973832) | Behring Diagnostics, Inc. | 1997-10-27 |
| N ANTISERUM TO HUMAN ALBUMIN (K972929) | Behring Diagnostics, Inc. | 1997-10-20 |
| N ANTISERUM TO HUMAN TRANSFERRIN (K972840) | Behring Diagnostics, Inc. | 1997-10-17 |
| MODIFICATION OF OPUS FERRITIN TEST SYSTEM (K973202) | Behring Diagnostics, Inc. | 1997-09-12 |
| OPUS D-DIMER (K972316) | Behring Diagnostics, Inc. | 1997-09-09 |
| VON WILLEBRAND REAGENT (K972116) | Behring Diagnostics, Inc. | 1997-07-25 |
| OPUS ETHANOL (K972011) | Behring Diagnostics, Inc. | 1997-07-22 |
| EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (K971600) | Behring Diagnostics, Inc. | 1997-06-25 |