PAPNET (R) TESTING SYSTEM
FDA premarket approval P940029/S001 · decided 1996-10-21
Approval details
- PMA number
- P940029
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PAPNET (R) TESTING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 1996-01-31
- Decision date
- 1996-10-21
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR A SECOND INDICATION FOR USE
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