PMA P920048
- Device
- Rapid fFN for the TLiIQ System
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S023
- Product code
- LKV
- Decision date
- 2026-08-26
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Approval order statement
- to modify the paper release liner used on the backing card for the manufacture of the Rapid fFN Cassette Kit of the TLiIQ System
Current openFDA PMA Record#
- Device
- Rapid fFN for the TLiIQ System
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S030
- Product code
- LKV
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Decision date
- 2026-08-26
- Decision code
- OK30
- Date received
- 2026-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the paper release liner used on the backing card for the manufacture of the Rapid fFN Cassette Kit of the TLiIQ System