The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/dl, Elitech Clinical Systems Urine Control Bi-level.
| Device ID | K122177 |
| 510k Number | K122177 |
| Device Name: | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2013-02-15 |
| Summary: | summary |