RIANEN I125
FDA premarket approval P800061/S001 · decided 1981-06-02
Approval details
- PMA number
- P800061
- Supplement
- S001
- Trade name
- RIANEN I125
- Generic name
- KIT, ASSAY, ESTROGEN RECEPTOR
- Applicant
- Dupont Legal
- Date received
- 1980-10-22
- Decision date
- 1981-06-02
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- LPJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wilmington, DE
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