FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Kit, Assay, Progesterone Receptor
PMA: P900025
·
Decision Sep 26, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Kit, Assay, Progesterone Receptor
- Trade Name
- FLUORO-CEP (R) PROGESTERONE
- PMA Number
- P900025
- Device Class
- FDA Class 3
- Product Code
- LPI
- Generic Name
- KIT, ASSAY, PROGESTERONE RECEPTOR
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 26, 1990
- Date Received
- April 11, 1990
- Expedited Review
- N
- Docket Number
- 90M-0442
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPI | Kit, Assay, Progesterone Receptor | FDA class 3 | Hematology |