Rapid fFN for the TLiIQ System

FDA Premarket Approval P920048 S023

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

DeviceRapid fFN for the TLiIQ System
Generic NameEnzyme Immunoassay, Fetal Fibronectin
ApplicantHOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS023 Date Received04/29/2022 Decision Date05/09/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-29
Decision Date2022-05-09
PMAP920048
SupplementS023
Product CodeLKV 
Advisory CommitteeToxicology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressHOLOGIC, INC.
1240 Elko Drive
sunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS023 Date Received04/29/2022 Decision Date05/09/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval To Eliminate An Incoming Inspection Of An Assay Reagent That Is A Component Of The Rapid FFN For The TLiIQ System; Transfer Of The Manufacturing Site For Assay Standards Of The Rapid FFN For The TLiIQ System; And Transfer Of The Manufacturing Site For The TLiIQ QCette Of The Rapid FFN For The TLiIQ System

Supplemental Filings

Supplement NumberDateSupplement Type
P920048Original Filing
S023 2022-04-29 30-day Notice
S022 2022-03-31 30-day Notice
S021 2022-02-14 30-day Notice
S020 2021-04-09 30-day Notice
S019
S018 2020-09-08 30-day Notice
S017 2020-07-10 30-day Notice
S016
S015
S014 2018-11-20 30-day Notice
S013
S012
S011 2015-06-10 Real-time Process
S010
S009 2015-04-09 Real-time Process
S008 2014-06-24 30-day Notice
S007
S006 2008-09-29 30-day Notice
S005 2007-12-21 Normal 180 Day Track No User Fee
S004
S003 2000-09-11 Normal 180 Day Track
S002 1998-02-13 Normal 180 Day Track
S001 1996-06-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045500884 P920048 006
15420045500877 P920048 006
15420045501171 P920048 008
15420045501164 P920048 008
15420045505346 P920048 009

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.