PMA P920048S005
- Device
- FULLTERM FETAL FIBRONECTIN TEST
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S005
- Product code
- LKV
- Decision date
- 2008-01-29
- Classification
- Enzyme Immunoassay, Fetal Fibronectin
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORP., MARLBOROUGH, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- FULLTERM FETAL FIBRONECTIN TEST
- Applicant
- Hologic, Inc.
- PMA number
- P920048
- Supplement
- S005
- Product code
- LKV
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Decision date
- 2008-01-29
- Decision code
- APPR
- Date received
- 2007-12-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORP., MARLBOROUGH, MASSACHUSETTS.