The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol Ii.
| Device ID | K151552 |
| 510k Number | K151552 |
| Device Name: | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ELITechGroup ZONE INDUSTRIELLE Sees, FR 61500 |
| Contact | Valerie Gourdon |
| Correspondent | Debra K Hutson ELITechGroup 21720 23rd Drive SE, Suite 150 Bothell, WA 98021 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-09 |
| Decision Date | 2015-07-08 |
| Summary: | summary |