FDA.reportPublic FDA data

PMA P920048S015

Device
Rapid fFN for the TLiIQ System
Applicant
Hologic, Inc.
Product code
LKV
Decision date
2020-11-06
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement
Approval for the addition of a sorting procedure for batching a cassette raw material into sub-lots during the manufacturing 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
S015
Product code
LKV
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date
2020-11-06
Decision code
APPR
Date received
2020-02-05
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of a sorting procedure for batching a cassette raw material into sub-lots during the manufacturing of Rapid fFN Cassettes for the TLiIQ System.