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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 NumberS025
Date Received11/22/2023
Decision Date12/21/2023
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  
a change to the sampling plan and procedure for in-process acceptance activities for cassette manufacturing. The cassettes are components of the Rapid fFN for the TLiIQ System: Rapid fFN Cassette Kit
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