PMA P920048S027

Device: Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S027
Product code: LKV
Decision date: 2024-12-06
Classification: Clinical Toxicology
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement: to add a new supplier for a component of the quality control and calibrator materials used for the Rapid fFN Control Kit and Rapid fFN for the TLiIQ System

Current openFDA PMA Record#

Device: Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S027
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2024-12-06
Decision code: OK30
Date received: 2024-11-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add a new supplier for a component of the quality control and calibrator materials used for the Rapid fFN Control Kit and Rapid fFN for the TLiIQ System