IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE
FDA premarket approval P920006 · decided 1995-09-26
Approval details
- PMA number
- P920006
- Trade name
- IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE
- Generic name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Applicant
- Abbott Laboratories
- Date received
- 1992-02-06
- Decision date
- 1995-09-26
- Days to decision
- 1328 days
- Decision code
- APWD
- Product code
- LPI
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT PGR-ICA MONOCLONAL
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