PMA P900013
- Device
- Pgr-eia Monoclonal
- Applicant
- Abbott Laboratories
- PMA number
- P900013
- Supplement
- S002
- Decision date
- 1999-09-22
Current openFDA PMA Record
- Device
- PGR-EIA MONOCLONAL
- Applicant
- Abbott Laboratories
- PMA number
- P900013
- Supplement
- S002
- Product code
- LPI
- Generic name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Decision date
- 1999-09-22
- Decision code
- APPR
- Date received
- 1999-09-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.