PMA P160037S003
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S003
- Product code
- MAQ
- Decision date
- 2019-11-22
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval for a post approval study labeling update.
Current openFDA PMA Record#
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S003
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2019-11-22
- Decision code
- APPR
- Date received
- 2019-08-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a post approval study labeling update.