THINPREP(R) PROCESSOR
FDA premarket approval P950039/S001 · decided 1996-08-22
Approval details
- PMA number
- P950039
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THINPREP(R) PROCESSOR
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 1996-06-07
- Decision date
- 1996-08-22
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR RELOCATION OF CYTYC CORP., FROM 237 CEDAR HILL ST., MARLBOROUGH, MA TO 85 SWANSON RD., BOXBOROUGH, MA
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510(k) clearances by this applicant
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| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
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| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
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