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 |