RIANEN 3H
FDA premarket approval P800061/S007 · decided 1985-03-26
Approval details
- PMA number
- P800061
- Supplement
- S007
- Trade name
- RIANEN 3H
- Generic name
- KIT, ASSAY, ESTROGEN RECEPTOR
- Applicant
- Dupont Legal
- Date received
- 1984-06-14
- Decision date
- 1985-03-26
- Days to decision
- 285 days
- Decision code
- APPR
- Product code
- LPJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wilmington, DE
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