BD Onclarity HPV Assay

FDA Premarket Approval P160037 S009

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

Manufacturing process scale-up

DeviceBD Onclarity HPV Assay
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantBECTON, DICKINSON AND COMPANY
Date Received2020-09-14
Decision Date2020-10-13
PMAP160037
SupplementS009
Product CodeMAQ 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BECTON, DICKINSON AND COMPANY 7 Loveton Circle sparks, MD 21152

Supplemental Filings

Supplement NumberDateSupplement Type
P160037Original Filing
S013 2022-11-21 30-day Notice
S012
S011 2022-10-21 30-day Notice
S010 2021-10-28 Real-time Process
S009 2020-09-14 30-day Notice
S008
S007 2020-07-06 30-day Notice
S006 2020-02-21 30-day Notice
S005
S004
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

NIH GUDID Devices

Device IDPMASupp
00382904440893 P160037 000
00382904419905 P160037 000
00382904440886 P160037 000
00382904429577 P160037 000
00382904429676 P160037 000
00382904438371 P160037 000
00382904440879 P160037 000
00382904439903 P160037 005
00382904439880 P160037 005
00382904440831 P160037 005
00382904453299 P160037 008
00382904453282 P160037 008

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