The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Envoy 500 Ck Reagent Kit.
| Device ID | K141265 |
| 510k Number | K141265 |
| Device Name: | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT |
| Classification | U.v. Method, Cpk Isoenzymes |
| 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 | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-15 |
| Decision Date | 2014-07-18 |
| Summary: | summary |