THINPREP SLIDES
FDA premarket approval P950039/S028 · decided 2014-04-24
Approval details
- PMA number
- P950039
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THINPREP SLIDES
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2014-04-02
- Decision date
- 2014-04-24
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- ADDITION OF A NEW RAW MATERIAL SUPPLIER FOR FLOAT GLASS USED TO MANUFACTURE THE THINPREP PAP TEST MICROSCOPE SLIDE.
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510(k) clearances by this applicant
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