The following data is part of a premarket notification filed by Elitechgroup with the FDA for Eltech Chinical System Amylase Sl Elitech Clinical Systems Elical2 Eltech Clinical Systems Elitrol I And Elitrol Ii.
| Device ID | K122858 |
| 510k Number | K122858 |
| Device Name: | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II |
| Classification | Catalytic Methods, Amylase |
| 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 | JFJ |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2012-10-03 |
| Summary: | summary |