THIN PREP PROCESSORS
FDA premarket approval P950039/S029 · decided 2014-09-12
Approval details
- PMA number
- P950039
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THIN PREP PROCESSORS
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2014-08-15
- Decision date
- 2014-09-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- THE FOLLOWING TEN CHANGES: QUALITY CONTROL (QC) INSTRUCTIONS FOR MICROSCOPE SLIDES INK AND CHIP, ADD A NEW FRICTION FEEDER EQUIPMENT, TP-00372 DOCUMENTATION UPDATE, ELECTRICAL SAFETY TESTING, TRANSFER OF LEGACY (LEGACY PMR) DOCUMENTATION INTO AGILE DOCUMENT CONTROL SYSTEM, INSTRUCTION CLARIFICATION REGARDING AIR VENT HOLES DURING MACHINE ASSEMBLY, MECHANICAL DRIVER BOARDS TESTING, PRESERVCYT QC TESTING, CHANGE IN OWNERSHIP OF LCD BOARD MANUFACTURER, AND IMPROVEMENT TO FIXTURES USED IN THE SCREEN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
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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 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886) | Hologic, Inc. | 2024-07-25 |