The following data is part of a premarket notification filed by Elitech Group with the FDA for Elitech Clinical Systems Creatinine Pap Sl, Elical 2, Elitrol I And Elitrol Ii, Urine Control Bi-level.
| Device ID | K132399 |
| 510k Number | K132399 |
| Device Name: | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL |
| Classification | Enzymatic Method, Creatinine |
| Applicant | ELITECH GROUP 21720 23RD DR S.E., SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson ELITECH GROUP 21720 23RD DR S.E., SUITE 150 Bothell, WA 98021 |
| Product Code | JFY |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-01 |
| Decision Date | 2014-01-03 |
| Summary: | summary |