BD Onclarity HPV Assay
FDA premarket approval P160037/S003 · decided 2019-11-22
Approval details
- PMA number
- P160037
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- BD Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2019-08-21
- Decision date
- 2019-11-22
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for a post approval study labeling update.
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