The following data is part of a premarket notification filed by Ibl Gmbh with the FDA for Tricat Ria (adrenalin/noradrenalin/dopamine); Katcombi Ria (adrenalin/noradrenalin); Noradrenalin Ria.
| Device ID | K051969 |
| 510k Number | K051969 |
| Device Name: | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA |
| Classification | Chromatographic/fluorometric Method, Catecholamines |
| Applicant | IBL GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus IBL GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Product Code | CHQ |
| CFR Regulation Number | 862.1165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-20 |
| Decision Date | 2005-10-03 |