PMA P920048S022
- Device
- Rapid fFN for the TLiIQ System
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S022
- Product code
- LKV
- Decision date
- 2022-04-13
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Approval order statement
- Change in incoming release criteria for the nitrocellulose component 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
- S022
- Product code
- LKV
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Decision date
- 2022-04-13
- Decision code
- OK30
- Date received
- 2022-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in incoming release criteria for the nitrocellulose component of the Rapid fFN for the TLiIQ System.