THINPREP PROCESSORS
FDA premarket approval P950039/S030 · decided 2014-09-26
Approval details
- PMA number
- P950039
- Supplement
- S030
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THINPREP PROCESSORS
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2014-08-29
- Decision date
- 2014-09-26
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR CLARIFICATIONS TO MANUFACTURING INSTRUCTIONS AND ADDITION OF SAFETY WARNINGS TO LABELING.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |