|
Device | FULLTERM FETAL FIBRONECTIN TEST |
Generic Name | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN |
Applicant | HOLOGIC, INC. 1240 Elko Drive Sunnyvale, CA 94089 |
PMA Number | P920048 |
Supplement Number | S005 |
Date Received | 12/21/2007 |
Decision Date | 01/29/2008 |
Product Code |
LKV |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORP., MARLBOROUGH, MASSACHUSETTS. |