PMA P160037S021

Device: Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S021
Product code: MAQ
Decision date: 2025-03-12
Classification: Microbiology
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval of the SHIP-Sub-Protocol LMI-001-A-S01_Version 3.0 for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160037-S017.

Current openFDA PMA Record#

Device: Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S021
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2025-03-12
Decision code: APPR
Date received: 2025-02-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the SHIP-Sub-Protocol LMI-001-A-S01_Version 3.0 for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160037-S017.