The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical Calibrator.
| Device ID | K093492 |
| 510k Number | K093492 |
| Device Name: | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Kathy Cruz |
| Correspondent | Kathy Cruz 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 | 2009-11-10 |
| Decision Date | 2010-03-19 |