FDA.reportPublic FDA data

PMA P920048S019

Device
Rapid fFN for the TLiIQ System
Applicant
Hologic, Inc.
Product code
LKV
Decision date
2021-05-21
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
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.

Current openFDA PMA Record#

Device
Rapid fFN for the TLiIQ System
Applicant
Hologic, Inc.
PMA number
P920048
Supplement
S019
Product code
LKV
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date
2021-05-21
Decision code
APPR
Date received
2020-10-30
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.