PMA P920048S006
- Device
- RAPID FFN FOR THE TLIIQ SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S006
- Product code
- LKV
- Decision date
- 2008-10-22
- Classification
- Enzyme Immunoassay, Fetal Fibronectin
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Approval order statement
- ALTERNATIVE MANUFACTURING PROCESS FOR THE RAPID FFN CASSETTE.
Current openFDA PMA Record#
- Device
- RAPID FFN FOR THE TLIIQ SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S006
- Product code
- LKV
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Decision date
- 2008-10-22
- Decision code
- OK30
- Date received
- 2008-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATIVE MANUFACTURING PROCESS FOR THE RAPID FFN CASSETTE.