The following data is part of a premarket notification filed by Elitech Group with the FDA for Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & Ii.
| Device ID | K110780 |
| 510k Number | K110780 |
| Device Name: | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-21 |
| Decision Date | 2011-10-07 |
| Summary: | summary |