EKF Life Sciences
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017101757 | 3017101757 | EKF Life Sciences | 1 | N | 2026-01-01 | 6879 Enterprise Drive Suite 500 South Bend IN US 46628 |
| 1832837 | 1832837 | EKF Life Sciences | 1 | N | 2020-04-25 | 1814 Leer Dr ELKHART IN US 46514 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 32126 | 1396758483 | K991598 | COBAS INTEGRA ACETAMINOPHEN | LDP | 1999-07-22 |
| 32126 | 1036113166 | K882038 | GDS ENZYMATIC SALICYLATE REAGENT | DKJ | 1988-06-24 |
| 32126 | 1872228757 | K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT | LDP | 1988-05-27 |
| 32126 | 1399010498 | K110726 | ROCHE ACETAMINOPHEN ASSAY | LDP | 2011-12-23 |
| 273539 | 1036113166 | ||||
| 273539 | 1091227799 | ||||
| 273539 | 1396758483 | ||||
| 273539 | 1399010498 | ||||
| 273539 | 1872228757 |