The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Calcium Arsenazo.
| Device ID | K151113 |
| 510k Number | K151113 |
| Device Name: | ELITech Clinical Systems CALCIUM ARSENAZO |
| Classification | Azo Dye, Calcium |
| 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 | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-27 |
| Decision Date | 2015-07-22 |
| Summary: | summary |