|
Device | Rapid fFN for the TLiIQ System |
Generic Name | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN |
Applicant | HOLOGIC, INC. 1240 Elko Drive Sunnyvale, CA 94089 |
PMA Number | P920048 |
Supplement Number | S014 |
Date Received | 11/20/2018 |
Decision Date | 12/17/2018 |
Product Code |
LKV |
Advisory Committee |
Toxicology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturer change of the desiccant tablet used in the Rapid fFN Cassette. The Rapid fFN Cassette is part of the TLiIQ System. |