PAPNET (R) TESTING SYSTEM
FDA premarket approval P940029 · decided 1995-11-08
Approval details
- PMA number
- P940029
- Trade name
- PAPNET (R) TESTING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 1994-09-21
- Decision date
- 1995-11-08
- Days to decision
- 413 days
- Decision code
- APWD
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE PAPNET TESTING SYSTEM
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