PMA P920048S021

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S021
Product code: LKV
Decision date: 2022-02-28
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement: Move of a suppliers manufacturing facility for a critical raw material (i.e., ascites fluid containing A137 mouse monoclonal antibodies) of the Rapid fFN for the TLiIQ System.

Current openFDA PMA Record#

Device: Rapid fFN for the TLiIQ System
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S021
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2022-02-28
Decision code: OK30
Date received: 2022-02-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move of a suppliers manufacturing facility for a critical raw material (i.e., ascites fluid containing A137 mouse monoclonal antibodies) of the Rapid fFN for the TLiIQ System.