PMA P920048S025

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S025
Product code: LKV
Decision date: 2023-12-21
Classification: Clinical Toxicology
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement: a change to the sampling plan and procedure for in-process acceptance activities for cassette manufacturing. The cassettes are components of the Rapid fFN for the TLiIQ System: Rapid fFN Cassette Kit

Current openFDA PMA Record#

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S025
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2023-12-21
Decision code: OK30
Date received: 2023-11-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the sampling plan and procedure for in-process acceptance activities for cassette manufacturing. The cassettes are components of the Rapid fFN for the TLiIQ System: Rapid fFN Cassette Kit