CEA-ROCHE TEST KIT
FDA premarket approval P800063/S004 · decided 1983-10-18
Approval details
- PMA number
- P800063
- Supplement
- S004
- Trade name
- CEA-ROCHE TEST KIT
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Hoffmann-La Roche, Inc.
- Date received
- 1982-12-15
- Decision date
- 1983-10-18
- Days to decision
- 307 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Nutley, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BHCG-ROCHE EIA (K850727) | Hoffmann-La Roche, Inc. | 1985-06-25 |
| RENAK (K831694) | Hoffmann-La Roche, Inc. | 1983-07-19 |
| ABUSCREEN RADIOUMMUNOASSAY--URINE (K830462) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (K830480) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (K830460) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (K830461) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (K830481) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (K830482) | Hoffmann-La Roche, Inc. | 1983-03-24 |