ThinPrep Genesis Processor
FDA premarket approval P950039/S040 · decided 2021-05-14
Approval details
- PMA number
- P950039
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ThinPrep Genesis Processor
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2020-09-30
- Decision date
- 2021-05-14
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval for the Hologic ThinPrep Genesis Processor.
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