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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 NumberS019
Date Received10/30/2020
Decision Date05/21/2021
Product Code LKV 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at 10210 Genetic Center Dr., San Diego, CA 92121 (GCD), for the manufacture of finished, kitted Rapid fFN Cassettes for use in the TLiIQ System.
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