The following data is part of a premarket notification filed by Diamond Diagnostics, Inc with the FDA for Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level.
| Device ID | K103364 |
| 510k Number | K103364 |
| Device Name: | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | DIAMOND DIAGNOSTICS, INC 333 Fiske St Holliston, MA 01746 |
| Contact | Liann Voo |
| Correspondent | Liann Voo DIAMOND DIAGNOSTICS, INC 333 Fiske St Holliston, MA 01746 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2011-05-06 |
| Summary: | summary |