CEA-ROCHE(R) EIA
FDA premarket approval P840027/S001 · decided 1986-09-08
Approval details
- PMA number
- P840027
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CEA-ROCHE(R) EIA
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Roche Diagnostics GmbH
- Date received
- 1986-06-17
- Decision date
- 1986-09-08
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Somerville, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Calcitonin (K252431) | Roche Diagnostics GmbH | 2026-04-24 |
| Accu-Chek FlexLink Plus infusion set (K143446) | Roche Diagnostics GmbH | 2015-08-13 |
| ELECSYS AFP (K981282) | Roche Diagnostics GmbH | 1998-05-01 |
| ELECSYS CALCHECK FERRITIN (K981281) | Roche Diagnostics GmbH | 1998-04-24 |
| ELECSYS CALCHECK CA 125II (K981278) | Roche Diagnostics GmbH | 1998-04-23 |