The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Sysems Ise Control 1 And 2.
| Device ID | K111996 |
| 510k Number | K111996 |
| Device Name: | ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2011-09-14 |
| Summary: | summary |