RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
FDA premarket approval P820052/S008 · decided 1991-08-06
Approval details
- PMA number
- P820052
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
- Generic name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Applicant
- Dupont Legal
- Date received
- 1991-02-15
- Decision date
- 1991-08-06
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- LPI
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Wilmington, DE
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