Rapid fFN for the TLiIQ System 510(k) FDA Approval

Device	Rapid fFN for the TLiIQ System
Generic Name	Enzyme Immunoassay, Fetal Fibronectin
Applicant	HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS021 Date Received02/14/2022 Decision Date02/28/2022 Product Code LKV Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received	2022-02-14
Decision Date	2022-02-28
PMA	P920048
Supplement	S021
Product Code	LKV
Advisory Committee	Toxicology
Supplement Type	30-day Notice
Supplement Reason	Process Change - Manufacturer/sterilizer/packager/supplier
Expedited Review	No
Combination Product	No
Applicant Address	HOLOGIC, INC. 1240 Elko Drive sunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS021 Date Received02/14/2022 Decision Date02/28/2022 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 the Move Of A Supplier’s Manufacturing Facility For A Critical Raw Material (i.e., Ascites Fluid Containing A137 Mouse Monoclonal Antibodies) Of The Rapid FFN For The TLiIQ System

Rapid fFN for the TLiIQ System