BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P160037 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a post approval study labeling update.

DeviceBD Onclarity HPV Assay
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantBECTON, DICKINSON AND COMPANY
Date Received2019-08-21
Decision Date2019-11-22
PMAP160037
SupplementS003
Product CodeMAQ
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address BECTON, DICKINSON AND COMPANY 7 Loveton Circle sparks, MD 21152

Supplemental Filings

Supplement NumberDateSupplement Type
P160037Original Filing
S003 2019-08-21 Normal 180 Day Track No User Fee
S002 2019-02-26 Real-time Process
S001 2018-04-27 135 Review Track For 30-day Notice

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