RIANEN 3H
FDA premarket approval P800061/S009 · decided 1985-07-23
Approval details
- PMA number
- P800061
- Supplement
- S009
- Trade name
- RIANEN 3H
- Generic name
- KIT, ASSAY, ESTROGEN RECEPTOR
- Applicant
- Dupont Legal
- Date received
- 1985-04-15
- Decision date
- 1985-07-23
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- LPJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wilmington, DE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.