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 | K130765 |
| 510k Number | K130765 |
| Device Name: | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ELITECHGROUP 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson ELITECHGROUP 21720 23RD DR 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 | 2013-03-20 |
| Decision Date | 2013-04-04 |
| Summary: | summary |