BD ONCLARITY HPV ASSAY
FDA premarket approval P160037/S022 · decided 2025-08-25
Approval details
- PMA number
- P160037
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BD ONCLARITY HPV ASSAY
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2025-02-26
- Decision date
- 2025-08-25
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for a manufacturing site located at Becton, Dickinson and Company, at 7 Loveton Circle, Sparks, MD, 21152, USA, for the manufacturing of the BD COR PX instrument.
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