BD Onclarity™ HPV Assay

FDA Premarket Approval P160037 S011

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

DeviceBD Onclarity™ HPV Assay
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantBECTON, DICKINSON AND COMPANY7 Loveton Circlesparks, MD 21152 PMA NumberP160037 Supplement NumberS011 Date Received10/21/2022 Decision Date11/19/2022 Product Code MAQ  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-21
Decision Date2022-11-19
PMAP160037
SupplementS011
Product CodeMAQ 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBECTON, DICKINSON AND COMPANY
7 Loveton Circle
sparks, MD 21152 PMA NumberP160037 Supplement NumberS011 Date Received10/21/2022 Decision Date11/19/2022 Product Code MAQ  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Modification To The Circuit Board Layout On The Instrumentation Module

Supplemental Filings

Supplement NumberDateSupplement Type
P160037Original Filing
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
00382904440879 P160037 000
00382904438371 P160037 000
00382904429676 P160037 000
00382904429577 P160037 000
00382904440886 P160037 000
00382904419905 P160037 000

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