PMA P920048S017
- Device
- Rapid fFN for the TLiIQ System
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S017
- Product code
- LKV
- Decision date
- 2020-08-12
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Approval order statement
- Relocation of a suppliers manufacturing site of a raw material used in the Rapid fFN Cassette. The Rapid fFN Cassette is part of the TLiIQ System.
Current openFDA PMA Record#
- Device
- Rapid fFN for the TLiIQ System
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S017
- Product code
- LKV
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Decision date
- 2020-08-12
- Decision code
- OK30
- Date received
- 2020-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of a suppliers manufacturing site of a raw material used in the Rapid fFN Cassette. The Rapid fFN Cassette is part of the TLiIQ System.