THINPREP 2000 SYSTEM
FDA premarket approval P950039/S004 · decided 1997-10-08
Approval details
- PMA number
- P950039
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINPREP 2000 SYSTEM
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 1996-10-02
- Decision date
- 1997-10-08
- Days to decision
- 371 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval for use of PreservCyt Solution as an alternative collection and transport medium for gynecologic specimens tested with the Digene Hybrid Capture System HPV DNA Assay.
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