PMA P920048S023

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S023
Product code: LKV
Decision date: 2022-05-09
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
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.

Current openFDA PMA Record#

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S023
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2022-05-09
Decision code: OK30
Date received: 2022-04-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.