The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Bilirubin Direct 4+1.
| Device ID | K171401 |
| 510k Number | K171401 |
| Device Name: | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | ELITechGroup Zone Industrielle Sees, FR 61500 |
| Contact | Valerie Gourdon |
| Correspondent | Terry Trimingham ELITechGroup 21720 23rd Drive SE, Suite 150 Bothell, WA 98021 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-12 |
| Decision Date | 2017-07-11 |
| Summary: | summary |