This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK) |
| Classification Name | Enzyme Immunoassay, Fetal Fibronectin |
| Generic Name | Enzyme Immunoassay, Fetal Fibronectin |
| Applicant | HOLOGIC, INC. |
| Date Received | 1992-10-20 |
| Decision Date | 1995-09-21 |
| Notice Date | 1996-07-08 |
| PMA | P920048 |
| Supplement | S |
| Product Code | LKV |
| Docket Number | 96M-0218 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 1240 Elko Drive sunnyvale, CA 94089 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920048 | Original Filing | |
| S023 | 2022-04-29 | 30-day Notice |
| S022 | 2022-03-31 | 30-day Notice |
| S021 | 2022-02-14 | 30-day Notice |
| S020 | 2021-04-09 | 30-day Notice |
| S019 | ||
| S018 | 2020-09-08 | 30-day Notice |
| S017 | 2020-07-10 | 30-day Notice |
| S016 | ||
| S015 | ||
| S014 | 2018-11-20 | 30-day Notice |
| S013 | ||
| S012 | ||
| S011 | 2015-06-10 | Real-time Process |
| S010 | ||
| S009 | 2015-04-09 | Real-time Process |
| S008 | 2014-06-24 | 30-day Notice |
| S007 | ||
| S006 | 2008-09-29 | 30-day Notice |
| S005 | 2007-12-21 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2000-09-11 | Normal 180 Day Track |
| S002 | 1998-02-13 | Normal 180 Day Track |
| S001 | 1996-06-26 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 15420045500884 | P920048 | 006 |
| 15420045500877 | P920048 | 006 |
| 15420045501171 | P920048 | 008 |
| 15420045501164 | P920048 | 008 |
| 15420045505346 | P920048 | 009 |