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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceRapid fFN for the TLiIQ System
Generic NameENZYME IMMUNOASSAY, FETAL FIBRONECTIN
ApplicantHologic, Inc.
1240 Elko Dr.
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
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.
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