PMA P850029
- Device
- ER-EIA MONOCLONAL
- Applicant
- Abbott Laboratories
- PMA number
- P850029
- Supplement
- S002
- Product code
- LPJ
- Decision date
- 1999-09-22
- Generic name
- KIT, ASSAY, ESTROGEN RECEPTOR
- Approval order statement
- Approval for adding "Caution: This Product Contains Natural Dry Rubber" to labeling.
Current openFDA PMA Record
- Device
- ER-EIA MONOCLONAL
- Applicant
- Abbott Laboratories
- PMA number
- P850029
- Supplement
- S002
- Product code
- LPJ
- Generic name
- KIT, ASSAY, ESTROGEN 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 labeling.