CEA-ROCHE(R) EIA
FDA premarket approval P840027/S004 · decided 1988-11-29
Approval details
- PMA number
- P840027
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- CEA-ROCHE(R) EIA
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Roche Diagnostics GmbH
- Date received
- 1988-10-27
- Decision date
- 1988-11-29
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Somerville, NJ
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