The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Glucose Hk Sl, Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I And Elitrol Ii.
| Device ID | K153644 |
| 510k Number | K153644 |
| Device Name: | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I And ELITROL II |
| Classification | Hexokinase, Glucose |
| Applicant | ELITechGroup ZONE INDUSTRIELLE Sees, FR 61500 |
| Contact | Valerie Gourdon |
| Correspondent | Terry Trimingham ELITechGroup 21720 23rd Drive SE, Suite 150 Bothell, WA 98021 |
| Product Code | CFR |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-09-07 |
| Summary: | summary |