RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
FDA premarket approval P820052/S005 · decided 1985-03-26
Approval details
- PMA number
- P820052
- Supplement
- S005
- Trade name
- RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
- Generic name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Applicant
- Dupont Legal
- Date received
- 1984-06-15
- Decision date
- 1985-03-26
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- LPI
- 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.