PMA P950039S004
- Device
- THINPREP 2000 SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S004
- Product code
- MKQ
- Decision date
- 1997-10-08
- Classification
- Processor, Cervical Cytology Slide, Automated
- Generic name
- Processor, cervical cytology slide, automated
- Approval order 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.
Current openFDA PMA Record#
- Device
- THINPREP 2000 SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S004
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 1997-10-08
- Decision code
- APPR
- Date received
- 1996-10-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.