PMA P920048S018

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S018
Product code: LKV
Decision date: 2020-10-02
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement: Addition of a manufacturing site at 10210 Genetic Center Dr., San Diego, CA 92121 (GCD) for the manufacture of critical components, proteins and protein conjugates, of the Rapid fFN cassette for theTLiIQ System.

Current openFDA PMA Record#

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S018
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2020-10-02
Decision code: OK30
Date received: 2020-09-08
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 92121 (GCD) for the manufacture of critical components, proteins and protein conjugates, of the Rapid fFN cassette for theTLiIQ System.