ABBOTT ER-EIA MONOCLONAL DIAG. KIT
FDA premarket approval P850029 · decided 1988-10-17
Approval details
- PMA number
- P850029
- Trade name
- ABBOTT ER-EIA MONOCLONAL DIAG. KIT
- Generic name
- KIT, ASSAY, ESTROGEN RECEPTOR
- Applicant
- Abbott Laboratories
- Date received
- 1985-05-17
- Decision date
- 1988-10-17
- Days to decision
- 1249 days
- Decision code
- APWD
- Product code
- LPJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Abbott Park, IL
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