PMA P920048S020

Device: Rapid fFN for the TLilQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S020
Product code: LKV
Decision date: 2021-04-29
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement: Addition of a manufacturing site at 10210 Genetic Center Dr., San Diego, CA (GCD) for the manufacture of critical components of the Rapid fFN for the TLiIQ System, namely the control kit, calibrators and other internal use-only components.

Current openFDA PMA Record#

Device: Rapid fFN for the TLilQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S020
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2021-04-29
Decision code: OK30
Date received: 2021-04-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a manufacturing site at 10210 Genetic Center Dr., San Diego, CA (GCD) for the manufacture of critical components of the Rapid fFN for the TLiIQ System, namely the control kit, calibrators and other internal use-only components.