FDA.reportPublic FDA data

PMA P920048S016

Device
Rapid fFN for the TLiIQ System
Applicant
Hologic, Inc.
Product code
LKV
Decision date
2020-09-03
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement
Approval for a change to the grade of cellulose acetate used in the manufacturing of nitrocellulose at a supplier. Nitrocellulose is used in the assembly of Rapid fFN Cassettes for the TLiIQ System.

Current openFDA PMA Record#

Device
Rapid fFN for the TLiIQ System
Applicant
Hologic, Inc.
PMA number
P920048
Supplement
S016
Product code
LKV
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date
2020-09-03
Decision code
APPR
Date received
2020-06-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the grade of cellulose acetate used in the manufacturing of nitrocellulose at a supplier. Nitrocellulose is used in the assembly of Rapid fFN Cassettes for the TLiIQ System.