The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elittech Clinical Systems Alp Ifcc Sl.
| Device ID | K113269 |
| 510k Number | K113269 |
| Device Name: | ELITTECH CLINICAL SYSTEMS ALP IFCC SL |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or 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 | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-04 |
| Decision Date | 2011-12-29 |
| Summary: | summary |