Rapid fFN for the TLiIQ System

FDA Premarket Approval P920048 S018

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 the addition of a manufacturing site at 10210 genetic center dr. , san diego, ca 92121 (gcd) for the manufacture of critical components, proteins and protein conjugates, of the rapid ffn cassette for thetliiq system

DeviceRapid fFN for the TLiIQ System
Generic NameEnzyme Immunoassay, Fetal Fibronectin
ApplicantHOLOGIC, INC.
Date Received2020-09-08
Decision Date2020-10-02
Product CodeLKV 
Advisory CommitteeToxicology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 1240 Elko Drive sunnyvale, CA 94089

Supplemental Filings

Supplement NumberDateSupplement Type
P920048Original Filing
S018 2020-09-08 30-day Notice
S017 2020-07-10 30-day Notice
S014 2018-11-20 30-day Notice
S011 2015-06-10 Real-time Process
S009 2015-04-09 Real-time Process
S008 2014-06-24 30-day Notice
S006 2008-09-29 30-day Notice
S005 2007-12-21 Normal 180 Day Track No User Fee
S003 2000-09-11 Normal 180 Day Track
S002 1998-02-13 Normal 180 Day Track
S001 1996-06-26 Normal 180 Day Track


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

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