PAPNET (R) TESTING SYSTEM
FDA premarket approval P940029/S003 · decided 1997-06-25
Approval details
- PMA number
- P940029
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PAPNET (R) TESTING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 1996-12-23
- Decision date
- 1997-06-25
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR SPECIFIC COMPUTER HARDWARE AND SOFTWARE CHANGES FOR THE REVIEW STATION COMPONENT OF THE PAPNET TESTING SYSTEM.
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