PGR-EIA MONOCLONAL
FDA premarket approval P900013/S002 · decided 1999-09-22
Approval details
- PMA number
- P900013
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PGR-EIA MONOCLONAL
- Generic name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Applicant
- Abbott Laboratories
- Date received
- 1999-09-16
- Decision date
- 1999-09-22
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- LPI
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.
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